Director, Regulatory Affairs CMC
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.
This position will be responsible for the global management and leadership of regulatory activities relating to global chemistry, manufacturing and controls (CMC/Quality) regulatory affairs function. This role is responsible for defining and executing global regulatory affairs CMC strategies pertaining to the development, registration and regulatory compliance of Retrophin products in the United States, European Union, Asia Pacific and Latin America. This includes interacting with the FDA, EMA and national Regulatory Agencies in the EU Member States and other health authorities as needed to ensure timely submission, approval and maintenance of company products.
- Define and execute the global CMC/quality regulatory strategy for Retrophin products including maintaining and extending product registrations in United States, European Union, Asia Pacific and Latin America markets.
- Designs global CMC/quality regulatory strategies in close collaboration with GRL to obtain, maintain and extend product registrations in US, Europe and ROW.
- Provide regional global CMC/quality regulatory expertise and work in collaboration with the GRL in organizing and providing support to meetings Health Authorities.
- Provide global regulatory strategic insight and regulatory procedural expertise in line with applicable directives and regulatory guidelines.
- Partner with global CMC/Quality regulatory stakeholders on strategies for Retrophin investigational and licensed products in all applicable regions, including but not limited to United States, European Union, Asia Pacific and Latin America.
- Collaborate closely with internal regulatory stakeholders (Strategy/Development, CMC, Labeling, and Operations) and regulatory staff at vendor and partner companies to ensure that all aspects of regulatory strategies are coordinated and considered.
- Assure accurate and timely compilation and submission of regulatory documentation.
- Lead the Retrophin Global CMC/Quality Regulatory function by providing direction, guidance, and mentorship to direct reports.
- Represent Retrophin Regulatory Affairs in Retrophin global CMC/quality matters and operations.
- Direct and lead cross-functional submission teams to ensure creation and submission of global CMC/quality regulatory documents (NDA, MAA, Briefing documents, Variations, ODD, PIP, responses to questions and other relevant regulatory filings) within defined timelines as per company objectives.
- Partner with functional stakeholders to ensure the timely submission, approval and compliance of global CMC/quality information for all IND/CTA applications conducted in the United States, European, Asia Pacific and Latin America region, as applicable.
- Establish and maintain strong working relationships with appropriate contacts at relevant regulatory agencies, especially the FDA, European Medicines Agency and regulatory agencies in the EU member states to ensure regulatory applications are approved in a timely manner.
- Remain knowledgeable about current regulations and guidance, interpret and notify appropriate personnel of any changes, updates or revisions.
- Communicate and collaborate with the partner organizations to ensure all parties are informed of activities directly affecting their market.
- As the global CMC/quality regulatory expert, ensure any necessary knowledge is transferred throughout the Regulatory team and internal stakeholders.
- Ensure applicable regulatory requirements are considered and appropriately incorporated into all programs, to adhere to compliance with appropriate regulations, guidelines and post market commitments.
- Support new Business Development initiatives including due diligence and regulatory technical assessments as needed.
- Bachelor's Degree in a scientific and/or Life Sciences discipline. Advanced degree preferred. Equivalent combination of education and applicable job experience may be considered.
- Minimum of 10 years in drug/biologics development in the pharmaceutical and biotechnology industry or Government Health Agency, with at least 5 years of experience in a regulatory leadership role.
- Demonstrated track record of successful approvals and extensive regulatory agency liaison experience is essential.
- Strong expertise and knowledge of the drug development process, Global submissions (eg NDA/MAA/NDS) and launch requirements is required.
- Strong understanding of US and European Union laws and procedures relating to drug market authorizations.
- 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.
- Capable of managing multiple projects and complex timelines in a team environment.
- Demonstrate 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.
- Ability to work independently under general supervision and exercise judgment within generally defined practices and policies.
- Ensure effective liaison with regulatory affairs counterparts to guarantee aligned representation and decision making at assigned teams.
- May require some domestic and international travel.
Retrophin, Inc. is an EEO/AA/Veteran/Disability Employer