Senior Specialist, Regulatory Affairs
As Senior Specialist, 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.
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, collaborative 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…
- 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.
- 4+ years experience in the pharmaceutical/biotechnology industry including at least 2-3 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
- Excellent interpersonal and organizational skills, with the ability to build relationships at all levels of the organization, including external
- Ability to travel up to 5%, domestic and
Competitive Compensation and Benefits include: Medical, Dental, and Vision Coverages, Life, AD&D, Disability, 401(k), Flexible Spending Plan, Stock Options and Fifteen vacation days per year and 11 paid holidays per year, which includes 1 floating holiday.
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 310.115
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.