Regulatory Affairs Director
Janssen Biologics B.V. - Leiden (Nederland)
For our client, Janssen Biologics B.V., we are looking for a Regulatory Affairs Director.
For this role, we are looking for a regulatory affairs expert who can support the regional regulatory strategy for products in the oncology pipeline and with in depth knowledge of the regulatory environment, guidelines and practice of EMEA regions.
- Advise the Project Team and/or Regional Therapeutic Area Leader on applicable regulatory issues, project-specific regulatory issues, and issues related to regional regulatory climates;
- Develop and ensure effective implementation of regional (central and national) regulatory strategy and tactics in support of the global development and life-cycle management plan;
- Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area;
- Provide input for developing and updating the Target EU SmPC based on an understanding of the implications of regional regulatory strategy for labeling;
- Ensure implementation of scientific advice / Regulatory Agency comments into development and life-cycle management plan;
- Establish and maintain strong relationships with Regulatory Agencies and effectively negotiate with Regulatory Agencies on product-specific labeling, study design, submissions content, and post-approval commitments;
- Advise team on required documents and processes to support Regulatory Agency contacts and submission;
- Provide input to and review submission documents to ensure that they are fit for purpose and support labeling statements;
- Ensure protocols are developed in alignment with regional registration strategies to support registration, reimbursement and competitive labeling;
- Advise team on required documents and submission strategies in preparation of CTA;
- Provide regulatory support throughout registration process and life-cycle management;
- Manage submissions, define submission plans, and advise team on required documents and submission strategies in preparation of MAAs (in collaboration with LOCs as appropriate);
- Responsible for submission and acceptance of MAA;
- Ensure country-specific submission packages are made available to the LOCs;
- Determine resource requirements for assigned projects and anticipate needs for major filings.
Who we're looking for
For this role, we are looking for a candidate with an M.Sc. in medical or paramedical (pharmacy, biology, veterinary etc.) and at least 10 years of regulatory experience in drug development and commercialization (e.g. experience in multiple products, multiple phases of development, multiple therapeutic areas). You have in depth knowledge of EU/EMEA regulatory procedures (CP, MRP, national) and experience in working in project teams and/or a matrix organisation.
As a person you have good people management skills, are an excellent communicator, organised and a multi-tasker.
Janssen Biologics creates, acquires and markets unique biopharmaceutical therapies. Their innovative products focus on the management of three major disease areas; cardiovascular, immunological disorders and cancer.
They strive to be a prominent company. Not only by the marketing of important new products. They also effectuate to increase the applications of their existing products. This means investing in the right research, forging the right business partnerships and hiring the right people to maintain the highest quality.
Additional vacancy information
|Contract||:||Temporary contract with CLS Services|
|Education||:||WO/MSc. PhD. HBO/BSc.|
|Employment terms||:||Temporary contract for 6 months. Flexible with onsite / remote work|
Days of leave: 25 + 11
See here our other employment terms for this vacancy
|Location||:||View location with Google Maps|
|+31 (0)88 22 77 555|
CLS Services is a leading professional recruitment agency, specialised in the recruitment and career coaching of people with a background in chemistry & life sciences.