Associate Director Global Regulatory Affairs Oncology
My client is a growing international biopharmaceutical company based in the French part of Switzerland with ongoing growth.
Due to this growth, my client is looking for an Associate Director Global Regulatory Affairs with strong experience working at global level and Oncology.
- Supports regulatory objectives, advice and strategy in alignment with department and corporate goals
- Works with multi-functional teams to ensure that regulatory requirements for the assigned products are achieved.
- Be the official liaison with European Regulatory Agencies and will support preparation and conduct of meetings with European Regulatory Agencies
- Plans and manages regulatory document preparation for regulatory submissions in Europe and in International geographies including CTAs, MAAs, Variations, Orphan applications, PIPs.
- Responsible for ensuring that the company is developing and executing optimal regulatory strategies for Europe and International geographies, and for preparing and supporting interactions with regulatory authorities appropriately
- Develop and lead globally aligned regulatory strategies for novel small molecule and biologics.
- Activities include Scientific Advice, Orphan Drug Designations, paediatric plans, registration procedures to optimize successful regulatory review and approval
- Review and interpret regulatory correspondences for global project teams
- Provide regulatory support to inter-departmental project teams and interact proactively with other functions, contract research organizations, partner companies, and health authorities
- Work with global regulatory team to agree contents for timely submissions to Health Authorities
- Plan and lead the preparation, review, and approval of compliant regulatory documents for European and International CTA and MAA submissions throughout the product lifecycle
- Coordinate the preparation of responses to questions and inquiries from Health Authorities.
- Prepare and submit CTA amendments, DSUR and MA Renewal in accordance with regulatory submission schedules and regulations.
- Work with Regulatory Operations group to ensure preparation of dossiers containing preclinical, clinical, and technical data in the required eCTD format
- Coordinate and support regulatory activities with affiliates and consultants including regulatory review of promotional materials by specific country RA affiliate/consultant
- Contribute to improvements in department operating procedures
- BS degree, preferably in a scientific discipline with a minimum of 8 years pharmaceutical / biotechnology experience and with a minimum of 5 years regulatory experience, preferably including one full submission or line extension through authorization
- Experience in interactions with regulatory agencies.
- Experience with clinical trial applications
- Expert project management and interpersonal skills is a requirement, as well as excellent written and verbal communication ability
- Experience in oncology and orphan products
Please send your CV to firstname.lastname@example.org