Director, Regulatory Affairs Strategy

Job Title: Director Regulatory Affairs Strategy     

Location:  Remote OR Menlo Park, CA OR Waltham, MA

Position Overview: The Director Regulatory Affairs Strategy provides global regulatory oversight and project leadership of assigned development products and reports to the Vice President Regulatory Affairs. The incumbent will be responsible for contributing to and implementing regulatory strategies and plans to expedite global product development, managing regulatory communications/interactions with health authorities, and ensuring compliance with applicable regional regulations. This position will interface closely with the cross-functional Development team, as well as with external consultants and advisors, to ensure regulatory plans and strategies are well integrated and supportive of overall corporate objectives.

Key Responsibilities:

Strategic Planning

• Represent the Regulatory Affairs department on multidisciplinary product development teams
• Develop and implement global regulatory strategy to support expedited product development for one or more programs
• Contribute to content and lead preparation of global product development plans, target product profiles, orphan drug designation applications, pediatric study plans, as applicable.
• Research regulatory precedent and current/emerging trends related to product class and therapeutic area(s) to identify risks and opportunities for development/registration

Regulatory Operations

• Manage global regulatory lifecycle of assigned investigational products, including maintaining project timelines, organizing submission content, and coordinating the internal/external authoring and review of components of original investigational drug applications, amendments, and safety and annual reports
• Interface with external Regulatory Operations group in the compilation and e-submission of regulatory documents
• Serve as primary liaison for communication with regulatory health authority on assigned programs
• Prepare team for and lead the conduct of milestone development meetings with regulatory health authority

Compliance

• Review and communicate current and emerging regulatory requirements for quality, preclinical, and clinical programs to ensure compliance of all development activities with applicable US and international regulations and guidelines
• Participate in the development and review of standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements
• Assist in the archival and maintenance of regulatory application submissions and correspondence.
• Monitor company progress toward fulfillment of regulatory commitments

Qualifications

Education

• Bachelor’s degree in a life sciences discipline; advanced degree preferred; Regulatory Affairs Certification a plus

Experience

• Minimum 8 years progressive pharmaceutical Regulatory Affairs experience with focus in development of drugs/biologics
• Direct experience in preparation, submission and lifecycle management of global investigational/marketing applications in eCTD format, including as primary Regulatory author
• Experience negotiating and directly interfacing with US and international regulatory authorities
• Product development in therapeutic areas of dermatology, immunology or inflammation a plus

Skills

• In depth knowledge of GXP/ICH guidelines and global regulations and systems
• Ability to interpret and apply complex and evolving regulatory guidance
• Strong written and verbal communication, analytical, organizational and interpersonal skills
• Excellent strategic planning and cross-functional project management skills
• Ability to work in a dynamic environment with a high degree of flexibility 

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, who will work remotely or Waltham, MA or Menlo Park, CA is $200,000-225,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Company is a multi-state employer and this salary range may not reflect positions that work in other states.

Job Location:

• Position is may be remote with the expectation to go on site in Menlo Park, CA OR Waltham, MA as needed OR on site in one of those locations where you will be required to be in-office 3 days/week.