We require a qualified Regulatory professional for a 12-month contract to take on leadership of one of our flagship products in the oncology space. Extensive experience of EU clinical regulatory affairs is required.
In this role, a typical day might include the following:
- Representation of Regeneron to EMA and EU National Agencies, as well as Alliance partners for key oncology asset.
- Assist Program teams in developing strategies that are EU-appropriate and take advantage of EU regulatory systems and processes.
- Navigate complex post-approval pathways to ensure full compliance with licensing obligations and on-time delivery of commitments.
- Lead submission activities for new indications, both process and strategy, to ensure timely product approvals with competitively differentiated labelling.
- Execute clinical trial applications for assigned program and provide leadership for team members responsible.
- Lead preparation responses to CTA challenges and perform CRO oversight as required.
- Ensure emerging issues are flagged to EU regulatory leadership in a timely manner.
This role might be for you if:
You have experience of bringing a product through EU approval
You have the ability to support EU Clinical Trial Applications through approval and study start up.
You are able to negotiate and concisely express clear positions to stakeholders at all levels.
We require a Degree in a scientific discipline, an advanced degree (Masters or PhD) is preferred. We need someone who has 10+ years regulatory experience with a focus on supporting products in the post-approval setting. Significant experience in the EU centralised procedure is crucial, and we also need experience in dealings with the EMA (scientific advice, orphan designation, PIPs) and national agencies.Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.