Senior Manager /AD Regulatory Affairs (Waltham)

The

Senior Manager/AD, Regulatory Affairs

serves as a Health Authority liaison and key member of project teams, establishes and communicates regulatory strategies for development programs, and coordinates the timelines, generation, and submission of complex regulatory dossiers.

The person in this role manages the planning, preparation, and submission of regulatory dossiers in support of project goals, including developing and maintaining submission plans and timelines. She/He also serves as the Regional Regulatory Lead (RRL) for assigned drug development programs. In addition, they will lead cross-functional teams to deliver high-quality submissions, e.g., INDs, NDAs/BLAs, meeting requests and briefing documents, orphan applications, pediatric study plans, etc.

Responsibilities: Manages the planning, preparation, and submission of regulatory dossiers in support of project goals, including developing and maintaining submission plans and timelines.
Serves as the Regional Regulatory Lead (RRL) for assigned drug development programs.
Keeps abreast of changing regulations, guidance documents, and technical/scientific developments relevant to projects, ensuring all work is compliant with regulatory requirements, and company policies and procedures.
Contributes to the generation of SOPs and work processes relevant to the regulatory scope of work.
Keeps abreast of changing regulations and health authority actions. Develops regulatory strategy for assigned projects, with supervisor oversight, in the region.
Accountable for regulatory dossier generation, content, and timeline, and strategy in the region.
Maintains knowledge of regulatory requirements and anticipates, assesses, and communicates changes in regulatory information to project teams, as relevant.
Serves as the primary liaison with Health Authorities for assigned products. Ensures all communications with regulators are properly documented, and aids in the interpretation of Health Authority feedback to the project team.

Qualifications / Requirements: Bachelor’s degree in life sciences
Must possess at least six (6) years of relevant regulatory experience and eight (8) years of experience within the pharmaceutical or biotechnology industry.
Proficient in Microsoft Office (Word, Excel, PowerPoint, Outlook).
Strategic thinker, able to interpret complex regulations and apply them appropriately, throughout the product development lifecycle,
Ability to quickly integrate information, define and mitigate risk, and prioritize activities among multiple projects.
Strong analytical skills and problem-solving capabilities.
Must have excellent communication skills (verbal and written). Must be able to effectively communicate with Health Authorities and with peer group members from diverse cultural backgrounds.
Ability to negotiate novel development and registration pathways for rare diseases.
Demonstrated ability to interact successfully in a dynamic and culturally diverse workplace, remotely and in person.
Demonstrate strategic regulatory leadership for assigned projects, in the region (US).
The incumbent may occasionally attend meetings at company sites, and relevant professional conferences. Travel could be scheduled based upon the needs of the business, up to 15% of the time, barring pandemic restrictions.