Senior Manager Regulatory Affairs
10 hours ago
We are seeking a highly skilled Senior Manager Regulatory Affairs to join our team at AbbVie. As a key member of our Global Regulatory Strategy team, you will be responsible for developing and implementing regulatory strategies for assigned products or product lines.
Key Responsibilities- Develop and implement regulatory strategies for assigned products or product lines, ensuring compliance with US and Canada regulatory requirements.
- Collaborate with cross-functional teams to ensure regulatory strategies are effectively implemented and maintained.
- Identify and gather data needed to support filings, responses to inquiries, and registration maintenance.
- Develop and maintain relationships with Health Authorities, including the FDA, to ensure timely and effective communication.
- Provide regulatory guidance and support to internal customers, including Public Affairs, Clinical Development, and Commercial teams.
- Develop and implement training programs for staff members to ensure regulatory knowledge and skills are up-to-date.
- Contribute to the development and review of regulatory submissions, ensuring compliance with US and Canada regulatory requirements.
- 6 years of experience in regulatory affairs, R&D, or industry-related experience.
- Advanced degree or certifications a plus.
- Excellent negotiation, problem-solving, and communication skills.
- Ability to work in a complex and matrix environment.
AbbVie offers a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees. This role is eligible to participate in our short-term and long-term incentive programs.
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.
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Senior Manager Regulatory Affairs
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