Director, Regulatory Affairs

ROLE: Director Regulatory Affairs

The Regulatory Affairs professional will help develop regulatory strategies and manage regulatory submissions in the US.

You will report to the Vice President of Regulatory Affairs and will work in a cross-functional matrix structure with other R&D functions.

MAIN RESPONSIBILITIES

• Provide US regulatory support for all products.
• Serve as global and US regulatory lead for programs in clinical development.
• Advise on regulatory strategies and operational plans from a US perspective (act as the US regulatory expert).
• Coordinate all aspects of regulatory submissions, including:
• Develop and manage regulatory project timelines.
• Provide regulatory guidance on requirements for IND filings.
• Coordinate preparation and review of regulatory documentation (INDs, IMPDs, clinical protocols, annual reports, labeling materials, meeting materials, briefing books, fast track and orphan drug designations, pediatric study plans, proposals for investigator-initiated trials, responses to agency queries, etc.).
• Work with the regulatory operations group for the preparation and submission of health authority documents.
• Serve as the primary interface with health authorities.
• Participate as a regulatory representative in relevant teams, advising on regulatory strategies, submission preparation timelines, processes, and requirements.
• Monitor and evaluate the US regulatory affairs environment and maintain an awareness of current and future risks that may impact business.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

• B.S. or M.Sc. degree in a scientific discipline with 7 years of experience in US Regulatory Affairs (Pharmaceutical or Biotechnology Industry).
• All-rounder profile with specific experience in managing submissions encompassing all areas of regulatory affairs (CMC, Clinical, Non-Clinical, etc.).
• Oncology regulatory experience preferred.
• Highly detail-oriented with the ability to interpret complex information via excellent written, presentation/oral communication, and customer service skills.
• Effective collaborator who can bring together multiple stakeholders and build positive relationships with both internal and external partners.
• Change-agility needed; must thrive in a dynamic, complex, and regulated environment.
• Based in Watertown, US.

LEADERSHIP CHARACTERISTICS

• Resourceful, collaborative, and detail-oriented.
• Approaches challenges with creativity and pragmatism. Ability to work in a fast-moving and challenging biotech environment.
• Ability to engage teams to achieve goals without direct authority.
• Driven to move the R&D programs forward at full speed while maintaining quality.

OFFER

• A stimulating position within a high-potential innovative biotech company.
• The opportunity to work in a science-driven, dynamic, respectful, and professional environment.
• A challenging scientific and business growth opportunity where you can bring your knowledge and skills.
• An employment agreement contract with an attractive salary package in line with the position responsibilities and your experience.

Job Type: Full-time

Pay: $210,000.00 - $275,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• 8 hour shift

Work Location: In person

Salary : $210,000 - $275,000