Author: Noemie Oliva

Business Developer

My client, a growing mid-size pharmaceutical services company, is currently growing their activities therefore looking for a Business Developer to join one of their office near Nice (France).This position offers home-based flexibility.

Under the local responsibility of the Head of Business Development France you are in charge of growing our business in France and Europe

YOUR RESPONSIBILITES

  • Account management
  • Develop existing and new relationships with key decision makers at targeted accounts
  • Prepare and achieve Sales Plan, achieve Sales Targets
  • Maintain high level of understanding, of the decision making process with all major sponsors
  • Ensure that all proposal/contract details, client meetings, RFP information and relevant updates are shared between the clients and the company
  • Develop relationship with leads or prospects to generate RFP
  • Organise Clients meeting, organize congresses,
  • Proposal development
  • Demonstrate cross functional collaboration with the Functional Heads beyond proposal development process
  • Review the Draft proposal
  • Ensure that all information will be delivered on time
  • Interact when necessary with the clients to collect necessary information
  • Submit proposal to the client and follow up
  • Manage bid defense process
  • Get all relevant information from the sponsor, organize meeting, collaborate with participants to the presentation, prepare rehearsal accordingly
  • Ensure regular communication with project teams in order to secure the potential for repeat business and maximize opportunities for feedback.
  • Support the Contract process and Collaborate with Legal Department
  • Participate to conferences and exhibitions as and when requested
  • Maintain Sales Force Data Base
  • With all relevant information related to RFPs, proposals, email (client and internal), territory business plans, meetings, conference calls …etc.
  • Ensuring that all client meetings, RFP information and relevant updates are captured and maintained within Sales Force

QUALIFICATION:

  • Master degree in Science; University degree in Business is a plus
  • At least 3-5 years’ experience as Business Developer in a pharmaceutical and/or CRO environment
  • Deep knowledge of the core business of a CRO and needs of the pharmaceutical industry
  • Service providers experience
  • Strong problem solving and communication skills required
  • Customer orientated, outgoing personality

Fluent in English, additional languages (French, German) are a plus

Type d’emploi : Temps plein

Senior Regulatory Affairs Expert

 In this challenging role you will be responsible for building regulatory strategy, determine applicable regulatory requirements, propose solutions to comply with regulatory requirements and manage product license registration with the appropriate regulatory authorities worldwide.

  • Prepare, coordinate and execute regulatory submission with: FDA /European Notified Bodies/Health Canada/Any other territories as appropriate
  • Actively participate in product development projects on a regular basis in order to provide guidance on regulatory requirements and to provide supporting regulatory documentatio
  • Review analytical data from development studies, performance evaluation studies, and clinical field trials to ensure regulatory requirements are met.
  • Liaise with regulatory authorities and external contract bodies and, in response to requests from these, to collate and interpret specialised information.
  • Advise the compagny staff and project team members on data and information required for successful license applications and co-ordinate their efforts to ensure that their contributions to regulatory applications are produced to an appropriate standard for submission.
  • Compile product information for the preparation of technical files and regulatory dossiers to support product licence applications worldwide
  • Ensure that changes are documented in accordance with quality system requirements and are communicated in a timely basis as appropriate to the Regulatory Authorities.
  • Providing support, guidance and training as needed to fellow team members to ensure maintenance of world class regulatory team.
  • Contribute to the design and implementation of regulatory processes and identify areas for potential improvement.
  • Contribute to the regulatory watch process by maintaining knowledge of new or update regulatory requirements, guidance and industry standards
  • Assist with the implementation of the Company’s Quality Policy

QUALIFICATIONS AND EXPERIENCE REQUIRED

  • Scientific degree with a minimum of 5 years of experience in regulatory within the Lifescience Industry
  • Previous experience in bringing a new product to market, significant experience of Design Control or Development project
  • Previous filing experience in EU and USA: BLA, PMA, 510(k), high class CE marking submission
  • Significant specialist knowledge of regulation as it applies to Medical Devices,  Drugs or Biologics as well as related industry standards
  • Ability to interface with regulatory authority
  • Good technical writing skills and ability to negotiate/convince

 

Ce poste vous intéresse?

Envoyez votre CV à l’attention de Nadia Schild : nadia.schild@axepta.com ou postulez directement sur notre site