Regulatory Affairs Specialist
3 weeks ago
Career Opportunities at Regeneron Ireland DAC
Job Summary:
We are seeking a highly skilled Senior Compliance Officer to join our team at Regeneron Ireland DAC. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with global regulatory and CMC requirements.
Key Responsibilities:
- Perform regulatory assessments of changes to ensure compliance with global regulatory and CMC requirements.
- Contribute to the regulatory submission form process, interpreting the current, approved, and planned clinical regulatory landscape.
- Review regulatory submissions to ensure all aspects of global regulatory and CMC compliance are met.
- Collaborate cross-functionally to support submission strategies and impacts on supply and regulatory release processes.
- Support the regulatory submission forms to support regulatory release and QP certification.
- Foster strong communication and working relationships between IOPS and Global Development.
- Keep management and all stakeholders informed of assessments, overall strategy, and project status.
- Work within procedures and systems for enhanced tracking of global regulatory submission packages and approval status.
Requirements:
- Minimum of 4+ years pharmaceutical/biotech industry experience, including a minimum of 3+ years of relevant CMC experience.
- Bachelor's degree in a relevant technical, scientific discipline.
What We Offer:
We have an inclusive and diverse culture that provides comprehensive benefits, including health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels.
Equal Opportunities Employer:
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.
Reasonable Accommodation:
The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.
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