Author: Marine Dollat

Senior Regulatory Affairs Specialist

My client is an innovating and dynamic Medical Device company currently expanding their Regulatory Affairs Team.

Due to this growth my client is looking for a Senior Regulatory Affairs Specialist with a strong FDA experience to join them in Geneva area.

This position will report to the Regulatory Affairs Head.

YOUR RESPONSIBILITIES:

  • This position will be focused on the registration of Class III medical devices, in particular on US and Asian countries:

– Preparation of registration dossiers (ex : technical documentation, PMA and IDE)

– Manage the follow-up of the registration procedures and preparation of responses to Competent Authorities questions

– Assist the team in the Regulatory evaluation of US changes (Change control)

– Manage the maintenance of registration dossiers (modifications and renewals)

  • Define the regulatory strategy in the framework of the development of new products in collaboration with internal departments
  • Prepare and support audits conducted by Notified Bodies and Competent Authorities
  • Be the regulatory affairs representative in the varied project teams
  • Key contact and support for distributeurs
  • Follow-up the regulatory monitoring for medical devices

YOUR PROFILE :

  • Minimum 5 years experience in a regulatory affairs position for medical devices, preferably in international area
  • Be familiar with US FDA regulations
  • Must be able to write clearly and strong analytical thinking (ability to compile data and summarize results)
  • Excellent knowledge of English language
  • Team player and enthusiastic individual, versatile and dynamic
  • Team-oriented personality
  • Ability to work in a dynamic environment
  • A first experience in project management would be a plus

For more details, please contact Marine Dollat at mdollat@axepta.com

Global RA Head

My client is an innovating, dynamic and growing international pharmaceutical company currently

expanding their regulatory team in Switzerland, Vaud Canton.

 

Due to this growth my client is looking for a Global RA Head to manage a team and ensure best regulatory strategy in compliance with local and international regulatory requirements for OTC drugs and more generally consumer products

 

YOUR RESPONSIBILITIES:

 

  • Management of RA submisssion-team and set priorities according business needs and managerial considerations
  • Act as Global regulatory representative Franchise Committee
  • Ensure best regulatory strategy in compliance with requirements
  • Represent the company in Health Authorities‘ meetings
  • Ensure professional development of individuals
  • Act as deputy RA Head upon request
  • Coordinate the writing and update of dossiers according to the current Regulation
  • Ensure regulatory intelligence and initiate modifications of formulations when needed
  • Bring strong expertise in regulatory affairs on cosmetics (EU regulation 1223/2009 but not limited )
  • Work closely with different departments (marketing, safety, toxicology, BD,..)
  • Work closely with external partner

 

 

YOUR PROFILE:                   

  • PhD or Master in Science or equivalent with minimum 15 year experience in a similar position.
  • Prior experience in global Regulatory Affairs including few years in the Consumer Care environment (OTC drugs/Cosmetics/Medical devices).
  • Knowledge and management record of frontier products category.
  • Strong experience in management of a big blockbuster brand across international US and Asia (japan/Korea)
  • Strong experience in team management
  • Strong leadership
  • Fluent in English
  • Mature interpersonal, communication and organizational skills.

 

For more details, please contact Marine Dollat at mdollat@axepta.com

Global RA Senior Manager

My client is an innovating, dynamic and growing international pharmaceutical company currently

expanding their regulatory team in Switzerland, Vaud Canton.

 

Due to this growth my client is looking for a Global RA Senior Manager to manage a team and ensure best regulatory strategy in compliance with local and international regulatory requirements for OTC drugs and more generally consumer products

 

YOUR RESPONSIBILITIES:

 

  • Act as Global regulatory representative of OTC products Franchise Committee
  • Ensure best regulatory strategy in compliance with requirements
  • Represent the company in Health Authorities‘ meetings
  • Act as deputy RA Head upon request
  • Coordinate the writing and update of dossiers according to the current Regulation
  • Ensure regulatory intelligence and initiate modifications of formulations when needed
  • Work closely with different departments (marketing, safety, toxicology, BD,..)
  • Work closely with external partner

 

 

YOUR PROFILE:                   

  • PhD or Master in Science or equivalent with minimum 7 year experience in a similar position.
  • Strong experience in global Regulatory Affairs in the Consumer Care environment (OTC drugs/Cosmetics/Medical devices)
  • Strong experience with external partner
  • Strong experience in team management
  • Fluent in English
  • Mature interpersonal, communication and organizational skills.

 

For more details, please contact Marine Dollat at mdollat@axepta.com

PMS Specialist

My client is an innovating, dynamic and growing international medical device company currently expanding their team in Switzerland, Geneva canton. Due to this growth my client is looking for PMS Specialist to join there regulatory affairs’s team.

YOUR RESPONSIBILITIES:

Act as interface between product surveillance and regulatory, Quality, Clinical R&D, and Marketing team to gather appropriately PMS data.

  • Ensure the interface between the Safety department and other services within the company (R&D, Clinical, Marketing, Regulatory Affairs and Quality)
  • Participate in the development of cross-functional document planning and review meetings
  • In connection to R&D and Clinical team, analyze, adapt and translate technical information related to the products into medical information suitable for the marketing team

Collect, trend and escalate data related to Post marketing Surveillance

  • Develop PMS plans, PMCF plans, PSURs, and PMCF reports
  • Participate to the development of the CER
  • Regulatory watch: PMS, clinical, MD vigilance, Medical Affairs
  • National health authorities website surveillance, including FSA (Field Safety Action)
  • In charge of the Scientific literature intelligence (performance and safety vs competitors)
  • Track competitors data performance (clinical studies) and safety (vigilance)

Ensure that post marketing procedures, processes and documentation meet the regulations in all Teoxane subsidaries

  • Participation in the activities of risk management in connection with the customer complaint process (map, tables and risk management)
  • Develop the risk management process with R&D-CA-RA-MA interfaces, and user table point of contact
  • Participation on various committees (Change Board, CAPA Board, Risk Board, Quality Committee)
  • Follow-up to the NCF, changes and CAPA in connection with medical affairs
  • Participation in the improvement of processes, procedures, instructions, forms, tools and database in relation to the activities of the Medical Affairs Department
  • Participation to Audits

YOUR PROFILE:

  • Master in regulatory affairs or equivalent with minimum 3/5 years experience in a similar position
  • Strong knowledge with medical devices 
  • Strong knowledge with QSM and risk management
  • Fluent in  English (speak and write)

For more details, please contact Marine Dollat at mdollat@axepta.com

Senior Expert Drug Design

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their team in Switzerland, Vaud Canton. Due to this growth my client is looking for Senior Expert Drug Design to contribute for the design and evaluation of future oral and topical drug.

 

YOUR RESPONSABILITIES:

 

  • Contributes to the implementation of the future Drug Design strategy axes and ensure the strategy for outsourcing choices (CRO, university,..) that best correspond to strategic choices.
  • Participates to the evaluation and prioritization of projects
  • Ensures the implementation of partnerships and technological solutions 
  • Leads to the design and evaluation of innovative molecules for future drug candidates in collaboration with CROs, for oral and topical projects.
  • Leads collaboration with CRO partners for all design components of future drug candidates for portfolio projects.
  • Ensures to maximizing the value proposition of Research and Development projects.
  • Contributes to maintain an innovative and competitive research project portfolio
  • Contributes to the management of the global research budget of SIG Rx.
  • Contributes to the visibility of the company at international level (conferences, collaborations, KOL etc. …).


YOUR PROFILE:

  • PhD in Organic Chemistry or PhD in Medicinal Chemistry with minimum 10 years experience in Drug Design
  • Strong knowledge in biology, pharmacokinetics, silico modelling techniques, the drug discovery process and team management.
  • You have demonstrated an experience of innovation and significant achievement in the field of Drug Design as well as in the field of systemic, oral or injectable medicines.
  • You have conducted collaborative research programs with external partners.
  • You have good knowledge of fields biology/therapy areas and pathologies.
  • You have good knowledge of the development processes and early clinical development in particular
  • Excellent teaching and presentation skills are expected, as well as an excellent leadership capacity with a multicultural and multidisciplinary team.
  • You have gained international recognition for your work (conferences, publications, patents).
  • You speak and write English fluently.

 

For more details, please contact Marine Dollat at mdollat@axepta.com

Senior Safety Advisor Cosmetics

My client is an innovating, dynamic and growing international pharmaceutical company in Switzerland, Vaud Canton. Due to this growth my client is looking for Senior Safety Advisor cosmetics to lead activities of safety and toxicology aspects for raw materials and finished products.

Senior Safety Advisor Cosmetics

YOUR RESPONSABILITIES:

Safety of raw materials:

    • Release safety certificate of raw materials for Development
    • Provide toxicological data of new raw materials
    • Management raw material data to support reg dossier (Safety parts, INCI)
    • Support Vigilance group, global customer service and project teams on safety and innovation support
    • Manage expertise for ingredients/products in terms of production issues
  • Leader to deliver Safety assessment of bulk/finished products and/or participate when contracted out and calculate safety margin of all ingredients per formula
  • Provide support for first assessment of a new cosmetic formula
  • Observe and give update of legislation changes regarding raw material and ingredients
  • Manage all outsourced activities within domain of expertise
  • Write safety section of dossier and defend product with Agencies as needed
  • Organize a Data base on safety ingredients for the unit
  • Establish KPIs and Track / monitors the performance to improve them further
  • Support all activities related to Safety in liaison with Claims Development and Product Development and provide necessary expertise and support decision globally in this field

YOUR PROFILE:

  • PhD master in toxicology /chemistry / pharmacy or equivalent with minimum 10 years’ experience in Safety assessment
  • Strong experience in cosmetics
  • Strong experience with safety and toxicology aspects.
  • Proof of safety assessor courses including certificates
  • Proven record of experience in safety assessments of ingredients and cosmetic products marked WW
  • Strong leadership skills
  • Excellent oral and written communication skills
  • Strong communication skills;
  • Expert level oral and written English

For more details, please contact Marine Dollat at mdollat@axepta.com

Medical Writer

My client is an innovating, dynamic and growing international medical device company currently expanding their clinical team in Switzerland, Geneve Canton.

Due to this growth my client is looking for a Medical/Scientific Writer.

The position will report to the Head of Clinical Development Department.

 

Your Responsabilities :

       Prepares and finalises clinical documents such as, but not limited to, CSRs and appendices, IBs, protocols and protocol amendments, summary documents, RMPs (initial and updates), regulatory responses, and briefing documents. Documents must be of high quality in terms of scientific content, as well as organisation per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency;

       Leads cross-functional document planning and review meetings

       Leads in a team environment with greater independence for longer-term activities, and takes a lead role on assigned projects concerning timing, scheduling, and tracking;

       Indirectly or directly leads or sets objectives for others on team projects and tasks; e.g., able to lead process working groups;

       The primary point of contact for Clinical Development Team for medical writing activities;

       Responsible for functional planning and metrics database updates for assigned program.

 

Ihr Profil :

       PhD or Master in elated Pharmaceutical Science with minimum 3 years experience of relevant regulatory medical writing

       Ability to function (and potentially lead) in a team environment;

       Demonstrates learning agility ;

       Builds solid and productive relationships with cross-functional team members;

       Strong project management skills

       Strong leadership skills

       Fluent in English and French

Clinical Data Manager

My client is an innovating, dynamic and growing international medical device company currently expanding their clincal team in Switzerland, Geneve Canton.

Due to this growth my client is looking for a Clinical Data Manager.

Your Responsibilities :

 

Ø Contribute to the definition and the implementation of EDC or paper case record form of clinical studies.

Ø Be in contact with the global authorities.

Ø Leverage EDC development outsourced to external partners and manage related activities including setting up of data transfer agreements and appropriate clinical database reconciliation with internal database (ie safety database)

Ø Act as EDC representative

Ø Setup and lead clinical trial data and EDC specifications, EDC design, edit checks programming

Ø Maintain current awareness of regulations, guidance documents (Data Management Plan, Data Validation Plan…), advisory committees, industry standards, appropriate archiving, GCP and interna SOPs.

Ø Manage user access to the clinical database. Ensure appropriate training is received.

Ø work closely with clinical project manager to ensure quality of clinical data throughout the clinical study lifecycle to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review or final database lock.

Ø Participate in the development and maintenance of Data management SOPs.

 

Your Profile :

Ø Minimum B.Sc. degree in Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science ;

Ø Minimum of 4 years of experience in clinical data management.

Ø Strong knowledge of CDISC standards is required ;

Ø Experience in biostatistics and/or SAS programming is a plus ;

Ø Strong critical thinking and problem solving skills ;

Ø Able to rapidly adapt to changing environment and circumstances ;

Ø Fluent in English and French.

Senior Expert CMC Biologics Development

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a Senior CMC Expert/Director with experience working on Biologics Product.

Responsabilities :

 

Ø Contribute to the definition and the implementation of the CMC strategy in line with the overall strategy
Ø Provide expertise and leadership in the development, communication and implementation of global CMC strategy in support of product portfolio execution
Ø Ensure a balanced approach to pharmaceutical development risk, understanding the impact to the business and enabling smooth approval of regulatory submissions
Ø Identify proactively critical CMC development issues, escalade them in a timely fashion, contribute to set and implement strategies for their resolution
Ø Review and approve CMC and quality documents (i.e. IND, CTA, BLA)
Ø Contribute to Quality by Design CMC development strategy (e.g Quality Target Product Profile).
Ø Act as POC of the Pharmaceutical Development Department in governance bodies and meetings
Ø Leverage the pharmaceutical expertise to proactively coordinate project cross functional CMC content, in close collaboration with Pharmaceutical Development Functions, external partners and Project Management
Ø Act as Pharmaceutical Development Representative in the Global Project Team
Ø Elaborate with the Heads of Function and SMEs a CMC project development plan including milestones, external costs and internal resources needs
Ø Elaborate with the Heads of Function and SMEs a risk management table, update it as necessary and escalade in a timely manner any critical risk
Ø Work closely with CMC Regulatory Affairs and ensure alignment regarding questions and strategies, driving development of science based argumentation to obtain buy-in of regulatory agencies, together with appropriate Heads of Function and SMEs
Ø Attend CMC meetings with Health Authorities (e.g. FDA, PMDA, EMA) and act as CMC representative
Ø Ensure liaison and coordination between Pharmaceutical Development Department and Operations
Ø Support external partner oversight and management of CMC Expertise
Ø Develop and nurture a network of CMC experts to support strategy
Ø Proactively contribute to implement regional regulatory requirements and guidelines that impact pharmaceutical development activities

Ø Maintain current awareness of regulations, guidance documents, advisory committees, industry standards, scientific literature and trends that are applicable to current and future Development
Ø Communicate this within the Team and to other staff, as appropriate, and provide key strategic pharmaceutical development expertise inputs to projects and cross-functional teams
Ø May publish/present in high quality journals/conferences
Ø Lead working groups to develop internal policy or guideline

 

Your profile :

 

Ø Pharmacist, PhD, MS in biological sciences, biochemical engineering, or a related discipline, concentration in microbiology, biochemistry might be a plus
Ø Minimum 15 years experience in the pharmaceutical industry and 8-10 years in CMC expertise supporting worldwide product development in the related field
Ø Demonstrated understanding of CMC development in the field of biologics (e.g. cell culture, upstream and downstream process, analytical sciences including characterization and comparability studies, combination product,  technology transfer), including Quality by Design methodology
Ø Demonstrated experience in developing and implementing CMC work plans to support phase appropriate activities, including management of timelines and budget
Ø Strong knowledge in developing and implementing risk management
Ø Strong experience in authoring/reviewing regulatory documents (e.g. IND/IMPD, BLA) and in supporting registration process
Ø Demonstrated ability to set CMC strategy and to interact with competent authorities
Ø Effective leadership, project management, interpersonal skills
Ø Excellent verbal and written communication (English)
Ø Ability to lead and promote changes
Ø Ability to solve complex problems and to propose innovative solutions
Ø Demonstrated knowledge of cGMP requirements

Senior Biostatistician

My client is an innovating, dynamic and niche international privately-owned biopharma company currently expanding their Statistic team in Switzerland, Lausanne area. Due to this growth my client is looking for a Senior Biostatistician to join their team.

YOUR RESPONSABILITES :

 

Ø Provide statistical programming expertise

Ø Coordinate all statistical programming related tasks.

Ø Works closely with all departements and CRO for all statistical programming related activities, including development and validation of ADaM.

Ø Create derived data set specifications for all assigned studies and integrated summaries.

Ø Review statistical analysis plans for all assigned studies and integrated summaries and provide comments to study biostatistician.

Ø Review annotated case report forms and provides comments.

Ø Contribute to process improvement initiatives as assigned.

 

YOUR PROFIL :

 

Ø Master’s or Bachelor Degree in Statistics,Computer Science, with an experience of minimum 5 years  in pharmaceutical industry.

Ø Strong SAS programming language

Ø Strong knowledge of CDISC Standards

Ø Good understanding in statistical methods used in statistical analysis.

Ø Good knowledge within GCP

Ø Fluent in English