Sr. Manager, Global Regulatory Affairs

Role Summary

The Sr. Manager, Global Regulatory Affairs (GRA) supports the regulatory strategy and execution for assigned programs, working closely with the Global Regulatory Lead (GRL) and cross-functional teams. This role contributes to the development and implementation of regulatory submissions across multiple regions, ensuring alignment with global regulatory requirements and timelines. The Manager also serves as a key point of contact for regulatory operations and external partners (e.g., CROs), and provides backup support for regulatory activities within the team.

Responsibilities

• Collaborate with the GRL to support regulatory strategy and execution for assigned programs.
• Participate in cross-functional project teams to provide regulatory input and ensure alignment on submission planning and labeling strategy.
• Lead or support the review of regulatory submission packages, including INDs, CTAs, NDAs/BLAs, and supplemental submissions.
• Manage health authority query responses, ensuring timely and accurate communication and resolution.
• Coordinate with Regulatory Operations and CROs to facilitate submission logistics and document delivery.
• Provide guidance on US labeling precedence and support implementation of US labeling across functions.
• Maintain and update regulatory systems (e.g., GRIT) to reflect submission approvals related to supply release.
• Serve as a backup for other regulatory team members during absences, ensuring continuity of regulatory support.

Qualifications

• Required: Bachelor’s degree with minimum of 5 years of experience in regulatory affairs within the pharmaceutical or biotechnology industry.
• Required: Strong knowledge and understanding of global regulatory requirements, including interpretation of regulations, guidelines, and policy statements.
• Required: Demonstrated ability to manage regulatory submissions across multiple regions and submission types (IND, CTA, NDA/BLA).
• Required: Excellent operational competencies, including planning, organization, and project management skills.
• Required: Strong oral and written communication skills, with the ability to clearly convey regulatory concepts and updates to cross-functional teams.
• Required: Proven ability to build collaborative relationships across functions and contribute to innovative problem-solving.
• Required: Experience with regulatory systems and tools such as Veeva Vault, Docubridge, and CTIS.
• Required: Ability to work independently and serve as a reliable team member in a fast-paced, matrixed environment
• Preferred: Management of CTA
• Preferred: Supporting BLA