Senior Regulatory Affairs Dossier Development and Operations
Are you looking for a challenging job in regulatory affairs? Do you have experience with Module 3 dossier development? This can be the right job for you! In this position you are responsible for developing the technical eCTD sections to support Regulatory CMC dossier applications. You will ...
WO / MBA
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences. For our client, <STRONG>Janssen Vaccines & Prevention</STRONG>, we are searching for a Senior Regulatory Affairs Dossier Development and Operations.
Janssen Vaccines & Prevention is dedicated to bringing meaningful innovation to global health. They focus on the discovery, development, manufacturing and marketing of vaccines and antibodies to protect people world-wide from infectious diseases.
Are you looking for a challenging job in regulatory affairs? Do you have experience with Module 3 dossier development? This can be the right job for you!
In this position you are responsible for developing the technical eCTD sections to support Regulatory CMC dossier applications. You will coordinate and provide technical oversight for the generation of the CMC dossier of marketing and clinical trial submissions. You coordinate the timeline, virtual documents and generation of the Quality module. You will represent the department on multi-functional project development teams to support regulatory filings.
Who we're looking for
- Author/drive sections of the CMC dossier and evaluate/ensure that final versions comply with regulatory requirements;
- Support the technical functions in the development of responses to health authority inquiries in support of clinical trials as well as marketing applications;
- Evaluate and ensure the completeness, accuracy, and compliance of data provided for all regulatory submission;
- Support dossier strategy / product development plan creation at a compound level;
- Direct responsibility for project budgets;
- Lead dossier authoring activities for late stage projects for regulatory filings;
- Identify business improvement areas and drives implementation of improvements;
- Develop process and business improvements and align with other departments as needed;
- Interface directly with CMC/Tech team members, Regulatory, JSC, external service providers and internal VPAD/PDMS customers such as GCO and TA;
- Combine technical expertise with management skills;
- Manage functional or project teams with up to 10 members.
The ideal candidate has a PhD with PostDoc and at least 3 years of relevant experience in regulatory. University degree with at least 6 years of relevant experience will also be considered. You have experience with Module 3 Dossier Development for premarketing INDs/IMPDs or MAA/BLA. Additionally you have experience with late stage development.Additional vacancy information
Contract: Temporary contract with CLS Services
Terms: Project for at least 8 months. Longer term possibilities anticipated. Full time strongly preferred, 32 hours discussable. Flexible on location though commitment expected to come to Leiden 1-2 days per week.
Contactperson: Claudia Erwich-Faaij
Phone: +31 (0)88 22 77 555