Director, Regulatory Affairs Strategy

Job description

This role is responsible for leading regulatory activities and teams for premarket and
influencing post-market regulatory projects. Functions with little oversight in addressing
tactical and strategic issues and manages regulatory activities and resources to meet
business objectives. Serves as a key member of the project team for late-development
and marketed products and is responsible for operational and tactical project
management to ensure satisfactory completion of regulatory milestones. The incumbent
should have a proven track record in labeling expansion across multiple territories. In
addition, the role ensures compliance with global regulatory requirements and
proactively anticipates and mitigates regulatory risks. The role functions with a large
number of cross functional teams and will work closely with the Clinical Regulatory
function.

Job requirements

Skill:

• Extensive knowledge of content development and regulatory document authoring, with proven experience in maintaining compliance with the eCTD document structure. Class III Medical Device and Part 3 combination product experience helpful but not required.
• Demonstrated competency in FDA, EU, ICH guidelines, especially regarding registration requirements for CMC, clinical development, statistical methodologies, toxicology, non-clinical research, and pharmacovigilance operations.
• PMDA Japan experience is helpful but not required.
• Skilled in preparing regulatory submissions for various therapeutic areas related to pharmaceutical products.
• Extensive experience and preparing and leading health authority interactions and meetings.
• Able to establish and maintain productive collaborations with stakeholders across
• Regulatory Affairs, R&D, Medical Affairs, Quality Assurance, Operations,
• Commercial, and Legal departments, including effective engagement with senior management.
• Experienced in team-based environments, consistently focusing on key deliverables and proactively resolving challenges constructively.
• Strong prioritization and project management skills, meeting deadlines while adapting and solving problems creatively in fast-paced settings.
• Advanced organizational abilities to ensure submission of high-quality dossiers, employing creative strategies to optimize workflows. Experience in leading the development of high-quality regulatory meeting briefing packages
• Exemplary verbal and written communication, effective interpersonal skills, and
• strategic negotiation expertise. Excellent presentation skills. Ability to keep management informed of progress.
• Proficient in EDMS systems, regulatory publishing, electronic submission processes, and Microsoft Office applications.

Experience

• At least 10 years' experience in , pharmaceutical, biotech, or medical device sector with
• at least 5 years’ as part of a regulatory affairs team. Experience with Class 3 Medical
• Device /Drug combination products helpful but not required.

Education:

• Master’s degree preferred in life sciences, pharmacy, or a related field.
• Professional certifications preferred, such as those from the Regulatory Affairs
• Professionals Society (RAPS).
• Bachelor's degree in a scientific or technical field required; advanced scientific or regulatory degree preferred.

Job benefits

• Medical, Dental, Vision Insurance
• Life/AD&D
• Short- and Long-Term Disability
• 401(K) with large company match
• Health Saving Account (HSA) and Flexible Spending Account (FSA) with company match
• Wellness Program
• Employee Assistance Program (EAP)
• Generous Paid Time Off (PTO)

Job Type: Full-time

Pay: $150,000.00 - $230,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Vision insurance

Work Location: Remote