Director/Sr Director Regulatory

 

Position Description:
The Director of Regulatory Affairs will serve as the global regulatory lead (GRL) on several immunology programs and will be responsible for developing the global regulatory strategy in collaboration with key internal stakeholders, as well as tactical implementation of that strategy
 
This position works cross-functionally with regulatory affairs and clinical development organizations to facilitate the completion of regulatory filing documentation according to company timelines. It also ensures adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as required.

Responsibilities:

• • Develop and implement competitive and effective global regulatory strategies for various immunology products including clinical, nonclinical and CMC aspects and identify potential risks and mitigation strategies associated with proposed strategies
  • Work in close collaboration with the development team leader and other cross-functional colleagues, including CROs to deliver sound, efficient development strategies and operational plans
  • Lead and manage the development and preparation of high-quality global submissions (including IND, CTAs, BLAs, and MAAs) for IGM early and late-stage programs in collaboration with the regulatory and project teams to support and accelerate clinical development and regulatory approval.
  • Represent Regulatory Affairs on assigned cross-functional development teams.
  • Lead communication with global Health Authorities (HA), such as FDA and EMA, including, planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.
  • Provide updates on strategic global regulatory intelligence, such as new regulations, guidance, competitive product applications, approvals, and their impact on IGM programs.
  • Anticipate issues and guide cross-functional teams on risk mitigation strategies for any development challenges.

Qualifications:

• • Level is commensurate with experience
  • Must have relevant immunology therapeutic area experience.
  • A minimum of 10 years of Regulatory Affairs experience in the biopharma industry; Significant experience in the therapeutic area of immunology/autoimmunity is strongly preferred
  • BS or higher degree in the life sciences; Advanced academic degree (Master’s or PhD) is a plus
  • Experience as a GRL providing strategic regulatory advice to project teams for the global development of products through all stages of development.
  • Extensive experience filing IND/CTAs and some experience with BLAs/NDAs/MAAs
  • Extensive knowledge of regulatory requirements for all stages of drug development in a global environment
  • Demonstrated success in proactively managing collaborative relationships with key internal and external stakeholders, including FDA and other Health Authorities
  • Proven ability to successfully lead regulatory meetings
  • Ability to work independently and to be innovative in tackling strategic and operational challenges
  • Experience managing direct reports is preferred
  • Must have strong verbal and written communication skills
  • Must be proficient with computer and standard software programs used in Regulatory Affairs