JOB DETAILS

Director, CMC Regulatory Affairs

CompanyViking Therapeutics, Inc.
LocationSan Diego
Work ModeOn Site
PostedFebruary 27, 2026
About The Company
Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel first-in-class or best-in-class therapies for the treatment of metabolic and endocrine disorders. Viking's clinical programs include VK2735, a novel dual agonist of the GLP-1 and GIP receptors for the potential treatment of various metabolic disorders. The company is evaluating its subcutaneous formulation of VK2735 in a Phase 3 obesity program that includes two Phase 3 clinical trials (VANQUISH-1 and VANQUISH-2). Concurrently, the company is evaluating an oral formulation of VK2735 in obesity. Viking is also developing VK2809, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the treatment of lipid and metabolic disorders. The compound successfully achieved both the primary and secondary endpoints in a Phase 2b study for the treatment of biopsy-confirmed non-alcoholic steatohepatitis (NASH) and fibrosis. In a Phase 2a trial for the treatment of non-alcoholic fatty liver disease (NAFLD) and elevated LDL-C, patients who received VK2809 demonstrated statistically significant reductions in LDL-C and liver fat content compared with patients who received placebo. The company's newest program is evaluating a series of internally developed dual amylin and calcitonin receptor agonists (or DACRAs) for the treatment of obesity and other metabolic disorders. In the rare disease space, Viking is developing VK0214, a novel, orally available, small molecule selective thyroid hormone receptor beta agonist for the potential treatment of X-linked adrenoleukodystrophy (X-ALD). In a Phase 1b clinical trial in patients with the adrenomyeloneuropathy (AMN) form of ALD, VK0214 was shown to be safe and well-tolerated, while driving significant reductions in plasma levels of very long-chain fatty acids (VLCFAs) and other lipids, as compared to placebo.
About the Role

Description

The Director, Regulatory Affairs CMC (RA CMC) will provide Regulatory Affairs CMC leadership for development teams throughout the development program (discovery, development, submission, approval and post-approval) of Viking Therapeutic’s candidate projects. The Director RA CMC will be responsible for the development of efficient and effective CMC regulatory strategies and in the implementation of those strategies to achieve commercial status and lifecycle success.


Essential Duties and Responsibilities

The main Regulatory Affairs responsibilities of this role include but are not limited to the following:

  • Develop regulatory intelligence as the basis for the formulation of efficient and effective CMC regulatory strategies with international scope
  • Implement developed regulatory strategies
  • Identify and implement tactics and positioning with other stakeholders (internal and external) to achieve the earliest possible approvals of all regulatory submissions
  • Represent the company as the primary regulatory CMC expert in corporate alliance team structures to facilitate the attainment of the corporate alliance objectives
  • Interact and negotiate with domestic and foreign regulatory agencies as the primary responsible party
  • Coordinate, draft, prepare and submit regulatory applications and documents
  • Take lead role in management of regulatory CMC activities for key projects and coordinate filing efforts between corporate disciplines
  • Identify and define key regulatory issues related to the manufacturing, testing and control of products as well as pre-clinical and clinical development, Ensure compliance with U.S. and international regulations
  • May be accountable for management of personnel and their individual development to support achievement their professional quests as well as those of the Company
  • Other duties as assigned

Requirements

Education and Experience

  • Minimum BS Degree in Pharmacy, Chemistry, Biochemistry, Pharmaceutical Science, or a biological/biomedical discipline
  • An advanced degree (Masters, PhD) and RAC certification or equivalent are preferred
  • At least 10 years of relevant biopharmaceutical industry experience

Knowledge and Skills 

  • Experience in a smaller, biotech company is a plus
  • Demonstrated leadership participation with U.S. and international submissions 
  • Working knowledge of FDA and EMA regulations, pharmacopeial requirements, the regulators, the regulatory approval process
  • Excellent track record in building effective relationships with regulatory authorities
  • Proven ability to apply regulatory knowledge to various situations and serve as a source for the competitive advantage of the Company
  • Experience managing the assembly and messaging of all components of regulatory CMC submissions during development (e.g. IND, IMPD) and for marketing applications (e.g. NDA, MAA)
  • A strong record of successful submissions for drugs and peptides therapeutics which include INDs, IMPDs, NDAs, MAAs, Annual Reports, Amendments, Supplements, etc. 
  • High degree of proficiency Microsoft Office Suite (i.e., Word, PowerPoint, etc.), Outlook Internet applications, WebEx, Zoom
  • High attention to detail and excellent proofreading and editing skills
  • Strong analytical, interpersonal, and well-developed problem-solving skills with the ability to work in a positive and collaborative fashion
  • Ability to multi-task, professional demeanor, strong attention to detail
  • Self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive attitude
  • Must be dependable; someone willing to go the extra-mile to get things done 
  • Team player with excellent oral, written and verbal communication skills

VIKING THERAPEUTICS

Viking Therapeutics, Inc., is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Viking Therapeutics also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.


Notice to Agency and Search Firm Representatives

Viking Therapeutics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Viking employee by a third-party agency and/or search firm without a valid written & signed search agreement, and assignment of specific position, will become the sole property of Viking Therapeutics, Inc. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.

Key Skills
Regulatory StrategyCMC Regulatory AffairsRegulatory IntelligenceRegulatory SubmissionsFDA RegulationsEMA RegulationsNegotiationRegulatory ComplianceProject ManagementAnalytical SkillsProblem-SolvingCommunicationLeadershipProofreadingEditingMicrosoft Office Suite
Categories
Science & ResearchHealthcareManagement & LeadershipLegal
Job Information
📋Core Responsibilities
The Director, RA CMC will lead the development of efficient and effective CMC regulatory strategies throughout the entire development program, from discovery through post-approval, aiming for commercial success. Key duties involve developing regulatory intelligence, implementing strategies, representing the company as the primary CMC expert, and managing interactions and negotiations with domestic and foreign regulatory agencies.
📋Job Type
full time
💰Salary Range
$165,000 - $205,000
📊Experience Level
10+
💼Company Size
56
📊Visa Sponsorship
No
💼Language
English
🏢Working Hours
40 hours
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