The growing need for EU-specific expertise on our development programs as well as to keep the company compliant on emerging EU legislation and processes has led to the need to create a new position based in one of our offices in Europe, including Dublin (Ireland). The role is positioned at the Director level to enable independent working and advanced regulatory input to interactions with EU Regulatory agencies. This role will be focused on supporting development activities for oncology programs with ongoing activities in phase 1 through phase 3 and the post-marketing setting.
JOB DUTIES:
- Where required, lead, manage and develop EU regulatory team members by serving as a resource for EU knowledge for the global regulatory and development teams and for the reporting EU regulatory team.
- Build the representation of Regeneron's EU regulatory function to EMA and EU National Agencies, as well as Alliance partners as required.
- Assist Development teams and Regulatory senior management in developing strategies that are EU-appropriate and take advantage of EU regulatory systems and processes, in particular the application of innovative regulatory pathways to our development products.
- Responsible for planning and ultimately leading MAA related processes and strategy to ensure timely product approvals with competitively differentiated labelling.
- Execute clinical trial applications for assigned programs and provide leadership for team members responsible.
- As needed, support activity with Business Partners to ensure the EU regulatory strategy meets Regeneron’s business objective.
- Monitor emerging legislation and guidance in the EU and contribute to ensuring company-level awareness and compliance (where appropriate).
- Provide support to department liaisons with their project specific communications and issues, including Agency meetings, responses to CTA challenges and CRO oversight as required.
- Ensure emerging issues are flagged to EU regulatory leadership in a timely manner.
JOB REQUIREMENTS:
- Advanced degree in a scientific discipline.
- 10+ years regulatory experience with a focus on supporting products through clinical development.
- Experience providing strategic regulatory input for the development of oncology drugs, ideally those that are biologics (e.g immune-oncology, bispecifics, CARTs)
- Experience in dealings with the EMA (scientific advice, orphan designation, PIPs) an advantage.
- Proven track record of supporting EU Clinical Trial Applications through approval and study start up.
- Ability to negotiate and concisely express clear positions to stakeholders at all levels.
- Experience of directly working with national regulatory agencies and leading agency meetings face to face.
- Experience of bringing a product through EU approval is a distinct advantage.
- Experience of managing and developing staff members desirable.
- Excellent written and verbal communication skills.
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 comprehensive benefits including health and wellness programs, fitness centers and equity awards, annual bonuses, and paid time off for eligible 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 parental 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.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
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