Senior Manager Regulatory Affairs

10 hours ago


Chicago, Illinois, United States AbbVie Full time
Job Summary

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.
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.
What We Offer

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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