Vice President Of Manufacturing & Cmc

Regulus Therapeutics, Inc. (Nasdaq: RGLS) is a biopharmaceutical company located in San Diego, California leading the discovery and development of innovative medicines targeting microRNAs.

We are currently seeking an experienced Vice President of Manufacturing / CMC to support our team. For more information, visit www.RegulusRx.com.

VICE PRESIDENT OF MANUFACTURING / CMC

This position reports to the Chief Financial Officer. The VP of Manufacturing/CMC will be responsible for the leadership and management of Regulus’s CMC function. Responsibilities include planning, coordinating, and troubleshooting all aspects of drug substance (DS), drug product (DP), and device development from early lead optimization through late-stage development and into commercial production. The successful candidate will work closely with R&D, Pharmaceutical Development, Legal, Finance, Business Development, and company consultants across multiple departments (Regulatory, Quality, Manufacturing, etc.).

Responsibilities:

• Provide leadership, direction, and management of the operations functions reporting directly to him/her.
• Establish and manage ICH stability studies on DS and DP with contract laboratories or CMOs.
• Author and coordinate CMC activities for new registration (IND, NDA), post-approval changes, annual reports, and contribute responses to agency queries.
• Work with the Regulatory group to assess risk and develop both the US and EU Regulatory strategy plans for early stage through drug approval.
• Oversee all CMC aspects, including DS & DP Formulation Development and Manufacturing, DP Device Development, Analytical Development, Quality Control, and Supply Logistics of clinical materials and eventual commercial production.
• Oversee all aspects of Analytical Development, including stability studies of both DS and DP while ensuring that product strategy and the deliverables are suitable and aligned with the Regulatory requirements for the given stage of development.
• Ensure that plans are in place to support the clinical development plans and global regulatory submission schedules. The strategy should include a manufacturing strategy considering future clinical and commercial demand, financial investment, and supply risks.
• Responsible for overseeing raw materials, DS, DP, device, and packaging and labeling CMOs by the implementation of strategy, selection and technical transfer, and routine clinical and eventual commercial production.
• Work with cross-functional teams and contribute to overall project goals, study designs, budgets, etc.
• Oversee project timelines, manage meetings, and ensure outsourced manufacturing and analytical research projects are tracking to plan, budget, and timelines.
• Provide guidance for project strategy, goals, budgets, timelines, and other operational activities.

Requirements:

• Current experience interacting with vendors for raw materials, DS, DP, combination products (pre-filled syringes and injection devices) packaging and labeling, and domestic and international shipping logistics.
• Experience taking DS, DP, and drug-device combination products from the design phase through commercial production.
• Must have strong communication skills.
• Experience in managing the outsourcing of analytical studies, formulations, and DS and DP manufacturing is essential.
• Experience leading integrated multi-disciplinary teams of both technical and functional areas.
• Strong knowledge of DS & DP parenteral manufacturing.
• A sound understanding of CMC regulatory requirements and direct experience with compiling and reviewing CMC sections for INDs of oligonucleotide DS and DP is highly desirable.
• The candidates will possess a Ph.D. in Chemistry, and/or Pharmaceutical Sciences and have greater than 15+ years of relevant experience. Candidates with a B.S. or M.S. with a commensurate experience level will also be considered. Experience with oligonucleotide processes and manufacturing is required.
• Extensive experience implementing technical, strategic, and operational planning.
• Must understand the regulatory and manufacturing aspects of Drug-Device Development.

The anticipated salary range for this role is $230,000 - $300,000. Individual pay may vary based on additional factors, including, and without limitation, job-related skills, experience, work location, and relevant education or training.

In addition, this position offers an annual bonus and eligibility to participate in stock and ESPP plans. Benefits offered include a retirement savings plan (with company match), paid vacation, and health benefits to include medical, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

For immediate consideration, please apply to [email protected]

You can visit our website to find out more about our company and culture: www.RegulusRx.com

NO PHONE CALLS PLEASE. PRINCIPALS ONLY

Regulus Therapeutics, Inc, is proud to be an EEO Employer