Senior Director, Regulatory Affairs

San Diego, California
Oct 08, 2020
Biotech Beach
Required Education
Bachelors Degree
Position Type
Full time
At Retrophin, our mission is to identify, develop and deliver life-changing therapies to people living with rare disease. Giving patients a chance, providing hope, is what drives us.

Retrophin recognizes that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of patients. Our work is rewarding, professionally and personally because we are making a difference and we are passionate about what we do.

We are seeking talented individuals with an entrepreneurial drive who will thrive in our collaborative, fast paced environment and share in our mission to help others. We are headquartered in San Diego, CA with additional offices in Dublin, Ireland.

Position Summary

The Senior Director, Regulatory Affairs is responsible for the management and leadership of regulatory development activities for assigned products. In this role, the Senior Director will represent Regulatory Affairs at core team and sub-team meetings and other scientific review teams. The Senior Director is responsible for development of relevant sections of global core dossiers for assigned products.

Key accountabilities include providing scientific and technical regulatory guidance and strategy to key internal stakeholders to advance the development of novel compounds and life cycle development of assigned products and assuring compliance with global regulatory standards and commitments.

Essential Responsibilities
  • Liaison responsibility on behalf of Regulatory Affairs for ensuring effective and professional technical relationships with internal drug development teams, external scientific experts in the drug development arena and health authorities.
  • Provide global regulatory strategic insight and regulatory procedural expertise in line with applicable regulatory guidelines.
  • Ensure accurate and timely compilation and submission of regulatory documentation.
  • Represent Regulatory Affairs at core team meetings including other assigned teams i.e. sub-teams, labeling and promotional reviews.
  • Apply influence and negotiation skills to drive development results and resolve issues.
  • Direct and ensure effective execution of optimal strategies for development programs in responsible areas.
  • Ensure global regulatory compliance standards and commitments are met.
  • Responsible for leading, developing, driving and maintaining regulatory and technical sections of global CTD filings to ensure compliance of global filings in line with company scientific data.
  • Establish global strategic consistency across regional regulatory submissions by contributing to and reviewing regional-specific technical strategic regulatory documentation.
  • Effectively monitor and ensure applicable regulatory requirements are considered and appropriately incorporated into all programs, ensuring compliance with appropriate regulations and guidelines.
  • Develop and establish quality and accuracy standards for global regulatory technical documentation.
  • Collaborate with key internal partners and other key stakeholders to support a globally effective organization.
  • Support new Business Development initiatives including due diligence and regulatory technical assessments as needed.
  • Develop and mentor junior members within regulatory on project requirements and submissions.

  • Bachelor's Degree in Life Science or other related discipline. Advanced degree preferred. Equivalent combination of education and applicable job experience may be considered.
  • Minimum of 12 years' regulatory experience in the pharmaceutical and biotechnology industry or Government Health Agency, with at least 8-10 years' experience in a regulatory leadership role.
  • Demonstrated track record of successful approvals from a major regulatory agency is required. Prior regulatory agency liaison experience is essential. Prior experience with advisory committees preferred.
  • Strong expertise and knowledge of the drug development process, NDA and launch requirements is required. Experience in drug safety, pharmacovigilance and/or risk management preferred.
  • Strong understanding of US laws and procedures relating to drug market authorizations, European Union a plus.

Additional Responsibilities
  • Strong ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions.
  • Excellent interpersonal, communication, analytical and organizational skills.
  • Strong influencing and negotiation skills.
  • Demonstrated ability to direct and manage multiple projects and complex timelines in a team environment.
  • Ability to function effectively in a global scientific and cultural arena.
  • Strong leadership capacity in a highly matrix working environment by interacting effectively with internal departments and external organizations
  • Excellent team management skills, ability to lead, train and mentor team members at all levels.
  • Work independently under general supervision. Exercises judgment within defined practices and policies.
  • Ensure effective liaison with regulatory affairs counterparts to ensure aligned representation and decision making at assigned teams.
  • Ability to travel 10-20% domestic and internationally.

Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer

Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer