SR. DIRECTOR, CMC REGULATORY AFFAIRS - South San Francisco, CA | Biospace
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SR. DIRECTOR, CMC REGULATORY AFFAIRS

Tricida, Inc.

Location:
South San Francisco, CA
Posted Date:
11/17/2016
Position Type:
Full time
Job Code:
Salary:
COMPETITIVE
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Tricida, Inc. is an innovative development stage biopharmaceutical company, founded in 2013.  We have recently closed Series C financing of $55M, thus raising $95M to complete our development program.  We are focused on the discovery and development of first-in-class therapeutics for metabolic, renal and cardiovascular disease. Tricida is led by a management team with an accomplished and proven track record in discovering and developing new therapeutics, with extensive experience in building successful companies around strong science and unmet medical needs.  

Reporting to the Vice President, Regulatory Affairs, you will contribute actively to the development and implementation of CMC regulatory strategies for Tricida’s investigational product.  In addition, you will be responsible for coordinating all aspects of CMC regulatory submissions, such as IMPDs, IND amendments, and NDA/MAA.  In this highly visible role, you will coordinate department planning in support of CMC projects and objectives, including advising the CMC/manufacturing team on compliance with regulations and guidelines, while ensuring that CMC regulatory strategy aligns with other Company strategic development goals.  

RESPONSIBILITIES INCLUDE:

•   Lead the development, review and submission of CMC filings in the US and ex-US, including IND amendments, IMPDs and annual reports and CMC sections of future NDA/MAA, for the Company’s lead polymer 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.
•   Review and assess the regulatory impact of change control/requests for the manufacturing, testing and release of drug substance and drug product.
•   Coordinate and prepare written responses to requests for CMC information from regulatory authorities.
•   Participate in CMC meetings with regulatory agencies.  
•   Maintain an advanced level of understanding and awareness of existing and emerging legislation and guidances related to CMC, and advise project teams accordingly.
•   Provide regulatory expertise and policy support for GMP.
•   Communicate with senior management to provide updates on regulatory activities, as needed.

Requirements

•   Bachelor’s degree in a scientific discipline, preferably in chemistry.
•   Minimum of 10 years of regulatory experience in the pharmaceutical/biotechnology industry with strength in CMC; experience in clinical and nonclinical is a plus
•   Demonstrated regulatory experience in coordinating the preparation of US and international regulatory submissions for drug/biologic products in late stage development
•   Experience with submitting documents to regulatory authorities in eCTD format
•   Strategic thinker, planner and implementer
•   Excellent organizational, communications and presentation skills
•   Ability to prioritize and manage multiple projects and tasks 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
•   Proficiency in Microsoft® Office (Word, Excel, PowerPoint) and Adobe Acrobat
•   Ability to travel up to 5%, domestic and international.


Competitive Compensation and Benefits include:  Medical, Dental, and Vision Coverages, Life, AD&D, Disability, 401(k), Flexible Spending Plan, and Pre-IPO stock options.  15 vacation days per year and 11 paid holidays per year, which includes 1 floating holiday.

Tricida is located in South San Francisco, CA.  

SEND RESUMES TO:  jobs@tricida.com and indicate Job Code SM001