Overview

The Director, Regulatory Affairs manages essential regulatory aspects (nonclinical, clinical) of product development.

The responsibilities include working with areas and project teams to support product development and approval. You have a knowledge of global rules, regulations, and guidance governing drugs and biologics in all phases of development.

This is a Flex role, which allows for work to be completed from home while our offices are closed due to a pandemic. Once the offices are re-opened, this role will typically require onsite work 2-3 days each week, or more depending on business needs.

Responsibilities :

  • Develop global regulatory plans, identify risk mitigation strategies, and influence project teams and subteams to maximize the likelihood of regulatory success.
  • Provide tactical guidance to allow the and efficient conduct of development programs, while maintaining compliance with ICH requirements, regional requirements, and scientific and company procedures.
  • Manage all types of regulatory documents/submissions and manage team member input to provide high-quality deliverables that meet regulatory standards, and corporate and program milestones.
  • Provide an essential review of documents related to clinical and non-clinical aspects of programs to ensure messaging is consistent with program strategy.
  • plan, prepare for and implement meetings and teleconferences with regulatory agencies.
  • Maintain knowledge of and monitor changes in current global rules, regulations, and guidance governing drugs and biologics in all phases of development, and knowledge of the therapeutic area(s).
  • Initiate or contribute to local and global process improvements which have a significant impact on business.

Requirements:

  • Minimum BA/BS degree in life sciences. Advanced degree preferred.
  • scientific background with at least eight (8) years of experience in Regulatory Affairs in the biotechnology or pharmaceutical industries.
  • and who can provide advice, identify risks, and implement plans and risk mitigation strategies?
  • Experience with global drug development regulations.
  • manage major submissions and projects to deadlines.
  • talk with regulatory authorities.
  • Experience in the preparation and filing of marketing applications is desirable
  • Experience with the development of drugs/biologics for rare diseases.

The following are some highlighted benefits, but not limited to:

  • Summer and Winter shutdown in addition to generous vacation benefit and many observed company holidays
  • Long-term Incentive and Employee Stock Purchase Plans
  • Paid parental, adoption, and caregiver leave
  • Wellness Offering
  • Deferred compensation for specific roles
  • Fitness reimbursement
  • Tuition Reimbursement
  • Professional development programs