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Senior Director of Regulatory Affairs, Specialty Pharmaceuticals

2 months ago

Chicago, Illinois, United States Meitheal Pharmaceuticals Inc Full time
About the Role

Meitheal Pharmaceuticals Inc is seeking a highly experienced Senior Director of Regulatory Affairs, Specialty Pharmaceuticals to lead our regulatory strategy for specialty pharma products. This is a critical role that will play a key part in the growth and transformation of our regulatory team.

Key Responsibilities
  1. Regulatory Strategy: Provide strategic regulatory guidance on specialty pharma, especially combination products to senior management and specific project teams, from portfolio development, project execution to life cycle management.
  2. Regulatory Compliance: Work closely with cross-functional teams and external consultants to ensure regulatory compliance throughout combination product development.
  3. Regulatory Risk Management: Proactively identify possible regulatory risk or issues and recommend mitigation measures or solutions.
  4. Regulatory Submissions: Prepare and participate in FDA meetings and EMA Scientific Advisory meetings for product development (Biosimilars, generic and innovative products), with focus on drug-device combination products.
  5. Regulatory Affairs: Prepare and review regulatory submissions and deficiency responses to FDA, EMA, and other regulatory agencies.
  6. Team Development: Work with Head of Regulatory Affairs department to build up competence and capacity to enhance the efficiency and productivity of project execution as well as the approvability of submissions.
  7. CMC and Regulatory Sciences: Provide support to CMC and regulatory sciences of specialty pharma products, including biosimilars/biologics.
Requirements

To be successful in this role, you will need:

  • Bachelor, Master, or Ph.D. degree in life sciences. An advanced degree is preferred.
  • Over 10 years related experience in product development and regulatory strategy, and/or regulatory affairs, with a minimum of 3 years in combination product area.
  • Experience in preparing comprehensive packages for meetings with FDA and other regulatory agencies, developing regulatory strategies to streamline development process for efficiency and cost-effectiveness, as well as addressing challenges and deficiencies of technical complexity.
  • Expertise in drug-device combination products, including peptides, biologics or biosimilars, are highly preferred.
What We Offer

As a Senior Director of Regulatory Affairs, Specialty Pharmaceuticals at Meitheal Pharmaceuticals Inc, you will enjoy:

  • Competitive salary and performance-based bonuses.
  • Comprehensive health, dental, and vision insurance.
  • Generous PTO and paid holidays.
  • Retirement savings plan with company match.
  • Professional development and training opportunities.