Sr. Manager/Manager, Regulatory Affairs
Tricida, Inc., is a pharmaceutical company focused on the development and commercialization of its late-stage investigational product candidate, TRC101, a non-absorbed, orally-administered polymer designed to treat metabolic acidosis in patients with chronic kidney disease (CKD). We are led by a management team with an accomplished and proven track record in discovering, developing and commercializing new therapeutics, with extensive experience in building successful companies around strong science and unmet medical needs. We recently completed a successful Initial Public Offering and our stock is listed on the Nasdaq Global Select Market under the symbol TCDA. We are expanding our existing group of exceptionally talented and well-motivated colleagues to develop and commercialize our first-in-class drug candidate, TRC101.
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…
As Manager, Regulatory Affairs, you will actively contribute to the development of Tricida’s investigational product by serving as the regulatory lead on a global clinical trial and supporting future marketing application submissions. Your responsibilities will include coordinating clinical and nonclinical regulatory submissions, such as IND/CTA and NDA/MAA submissions, supporting new and ongoing clinical trials, and providing guidance to project teams regarding regulatory submission strategy and requirements that are consistent with current regulations, guidelines and industry standards.
- Represent Regulatory on the clinical project team for a global clinical trial.
- Lead the preparation and/or review of clinical and nonclinical filings in the US and ex-US, including IND amendments, CTAs, and annual or other periodic reports, and future NDA/MAA submissions for Tricida’s lead polymer product.
- Perform regulatory review of clinical and nonclinical study documents (e.g., protocols, ICFs, IB, safety reports/narratives, and study labels) for adherence to regulations, guidelines, commitments and strategies.
- Manage regulatory timelines for assigned projects and ensure consistency with project timelines.
- Coordinate written responses to information requests from regulatory authorities.
- Proactively mitigate potential risks and partner effectively and positively to solve issues.
- Support preparation for, and participate in, GCP inspection activities and other regulatory compliance-related activities as needed.
- Maintain an understanding and awareness of existing and emerging legislation and guidelines that may affect Tricida products and advise project teams accordingly.
- Conduct regulatory research on competitor activity and positioning.
- Contribute to the development and maintenance of Regulatory Affairs working practices and procedures and review other company procedures, as needed.
Experience and Skills:
- Bachelor’s degree, preferably in a science or similar discipline.
- 5+ years experience in the pharmaceutical/biotechnology industry including at least 3 years in Regulatory Affairs.
- Demonstrated regulatory experience in coordinating the preparation of US and international regulatory submissions for drug/biologic products, preferably in late stage development.
- Experience with submitting documents to regulatory authorities in eCTD format.
- Experience with NDA submission(s) a plus.
- Strong knowledge of FDA/ICH regulations and guidelines, particularly GCPs.
- Strategic and flexible thinker, planner and implementer.
- Excellent organizational, communications and presentation skills.
- Ability to prioritize and manage multiple projects and tasks with flexibility in a fast-paced biopharmaceutical company.
- Experience working in cross-functional, global, virtual environments.
- Excellent interpersonal and organizational skills, with the ability to build relationships at all levels of the organization, including external vendors.
- Ability to travel up to 5%, domestic and international.
Competitive Compensation and Benefits include: Medical, Dental, and Vision Coverage, Life, AD&D, Disability, 401(k), Flexible Spending Plan, and Stock Options. 15 vacation days per year and 11 paid holidays per year, which includes 1 floating holiday will be provided as per company policy.
Tricida is located in South San Francisco, CA and this is an on-site position
To apply for this position, please send resumes to email@example.com and indicate Job Code 310.113
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.