Our client is a leading provider of non-opioid pain management and regenerative health solutions. They are seeking a Vice President Regulatory CMC to lead CMC Regulatory strategies for their commercial and development programs, and oversee an established team. This is replacing the current VP who is retiring in January. With three marketed products and a strong pipeline, this company offers a passionate, small-company environment, with the opportunity to wear many hats. Now is an exciting time to join this growing organization and help advance patient care!
Responsibilities:
- Develop and lead implementation of CMC regulatory strategy to ensure timely and successful achievement of key Regulatory milestones for programs in development
- Ensure effective post-approval Regulatory response and compliance for commercial products.
- Directly oversee the Regulatory CMC group and provide support for manufacturing facilities in the US and UK.
- Oversee the CMC regulatory new product development function in supporting formulation and preclinical development programs, including new IND, sNDA, NDA and other filings in the US and globally.
- Work with internal and external manufacturing and commercial partners in support of US and ex-US regulatory filings for products.
- Identify, develop, implement and maintain global CMC regulatory procedures and systems.
- Lead and oversee the preparation of CMC Regulatory documents and filings in all phases of development and post-approval.
- Hire, manage and develop CMC Regulatory Affairs staff to ensure they deliver expected levels of excellence.
- Collaborate with all functional areas of the company, especially Manufacturing, Quality, and R&D area.
- Develop and implement regulatory strategies that will shorten approval times and improve product labeling.
- Oversee the management of marketed products, ensuring all reporting obligations are met for both the FDA and other regulatory bodies.
- Liaise effectively with domestic and international regulatory agencies.
- Participate in regulatory interactions with and presentations to regulatory agencies, customers, and partners.
- Prepare and/or monitor the preparation of high quality, timely regulatory submissions.
- Ensure conformance to commitments to various health agencies including FDA, EMA, MHRA, and ROW authorities.
- Plan future resource and budget needs to ensure continued strong CMC regulatory support to match company growth.
- Provide organizational support to the SVP of Regulatory Affairs to ensure effective communication within the department and with senior members of the organization.
Background and Qualifications:
- Bachelor’s degree in a scientific discipline such as chemistry, biology, pharmacy, or engineering. Advanced degree preferred.
- Minimum of 15 years of progressively responsible experience in Regulatory CMC for drugs in development and approved products.
- At least 8 years of experience managing people.
- Must have Regulatory CMC experience with sterile products and small molecule drugs. Experience with biologics and gene therapy programs a plus.
- Regulatory experience with Medical Devices desirable but not required.
- Ability to identify emerging Regulatory issues and initiate actions.
- Strong experience working with FDA required. Experience with EMA, Health Canada, and other global health authorities preferred.
- Demonstrated knowledge of global (U.S., EU, UK, and ICH) regulatory requirements and the ability to apply knowledge, both strategically and operationally to develop projects and marketed product regulatory issues
- Expert working knowledge of regulations and specific experience in CMC regulatory affairs, and the ability to support multiple products.
Interpersonal, Leadership, and Soft Skills:
- Proven ability to hire, build, and lead a Regulatory CMC team.
- Demonstrated strong negotiating and problem-solving skills.
- Proven ability to manage multiple projects, set priorities and meet deadlines.
- Demonstrated excellent technical writing skills.
- Excellent verbal and written English communication skills.
- Must be comfortable in a small company environment. Able to be flexible and comfortable with ambiguity.
- The successful candidate will have a results/problem solving orientation supported by strong project planning and leadership skills.
This is a hybrid/onsite position in the San Diego Area. Local candidates are preferred but open to remote candidates who are willing to travel regularly. Relocation package possible for the right candidate.
The budgeted salary range for this position is $290,000 to $320,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate’s skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of remuneration.