Senior Manager/Associate Director, Regulatory Affairs – CMC
We are currently seeking a qualified, highly motivated, experienced individual for the position of Senior Manager/Associate Director, Regulatory Affairs – CMC. A qualified candidate in this position will be responsible for developing, coordinating and managing CMC regulatory submissions, such as IMPDs/IND amendments, NDA/MAA and post-approval submissions. The candidate will contribute to the development and implementation of CMC regulatory strategies for late phase development and commercialization of Tricida’s polymer product. This position will be integral in the day-to-day functioning for CMC Regulatory and will collaborate with several key groups including CMC, Quality Assurance, and Project Management.
WE CAN OFFER YOU:
- The chance to join a successful and growing organization with an unmatched leadership team, passionate about their employees.
- An opportunity to make a real impact on chronic kidney disease patients with our cutting-edge therapeutics.
- A supportive, collaborate work environment, with colleagues who care about the success of the organization.
- A place that will treat you fairly, provide competitive compensation, on-going recognition, and most of all, a chance to learn, contribute and develop your skills.
- Fun, enthusiasm, support, a passion for healthy living and never a dull moment…
- Manage the development, review and submission of CMC filings in the US and ex-US, including IND amendments, IMPDs, annual reports and CMC sections of NDA/MAA and post-approval submissions, for the Company’s polymer product.
- Review and assess the regulatory impact of change control/requests for the manufacturing, testing and release of drug substance and drug product.
- Support the supply of ongoing clinical studies and commercial product.
- Review technical reports, specifications, and other documents supporting drug substance and drug product manufacturing for adherence to regulations, guidances, commitments and strategies.
- Represent Regulatory on project teams to outline submission requirements and define timelines for on-time delivery of high-quality regulatory CMC submissions.
- Coordinate and prepare written responses to requests for CMC information from regulatory authorities and briefing documents for meetings with regulatory authorities.
- Participate in CMC meetings with regulatory authorities as needed.
- Maintain an advanced level of understanding and awareness of existing and emerging legislation and guidance related to CMC and advise project teams accordingly.
- Provide regulatory expertise and policy support for GMP.
- Communicate with team members and management to provide updates on regulatory activities, as needed.
EXPERIENCE AND SKILLS:
- Bachelor’s degree in a scientific discipline, preferably in chemistry or engineering.
- Minimum of 5 years’ experience with increasing regulatory responsibility in CMC in the pharmaceutical/biotechnology industry
- Demonstrated regulatory experience in the preparation of CMC regulatory submissions for marketed (commercial) drug/biologic products
- Experience with submitting documents to regulatory authorities in eCTD format
- Strong knowledge of FDA, EU and ICH guidelines and regulations governing CMC
- Ability to think critically, plan and implement
- Excellent organizational, communication and interpersonal skills, including the ability to work cross-functionally in a global environment and with external vendors
- Ability to prioritize and manage multiple projects and tasks in a fast-paced, biopharmaceutical company
- Excellent written and spoken English
- Proficiency in Microsoft® Office (Word, Excel, PowerPoint) and Adobe Acrobat
- Ability to travel approximately 5%, domestic and international
Competitive Compensation and Benefits include: Medical, Dental, and Vision Coverages, Life, AD&D, Disability, 401(k), Flexible Spending Plan, stock options. 15 vacation days per year and 11 paid holidays per year, which includes 1 floating holiday will also be provided according to company practice.
Tricida is located in South San Francisco, CA.
SEND RESUMES TO: email@example.com and indicate Job Code 310.157
Tricida is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.