This job is archived
(Archived) Regulatory Affairs Manager-CMC (Remote)
Vetoquinol USA Inc. is a dedicated family of caring professionals creating industry leading products, services and financial results. Driven by purpose, guided by our core values of trust, dare and collaborate, we proudly provide life-enhancing solutions for animals and the people who care for them.
The Regulatory Affairs Manager (CMC) supports the regulatory development, strategies, and life-cycle management of veterinary products pre- and post-approval for Vetoquinol USA Inc. The Regulatory Affairs Manager (CMC) reports directly to the National Scientific Affairs Manager for Vetoquinol USA Inc. and works closely with commercial Product and development Project Teams in building and executing regulatory CMC strategies and submissions. They will serve as a contact/agent with US regulatory agencies for CMC-related concerns on behalf of Vetoquinol USA Inc. As part of the Vetoquinol USA Regulatory Affairs team, the Regulatory Affairs Manager (CMC) will work collaboratively with other Regulatory Affairs Managers and CMC-specialists from the Scientific Division (R&D) or MS&T (manufacturing site) organization in support of pre- and post-approval CMC submissions.
Dossier Submissions/ Maintenance
- Collaboratively, with GROUP functions, develops, facilitates and executes comprehensive US Regulatory CMC strategies to accelerate and ensure successful product registration and continued commercialization for both new and existing portfolios of veterinary products.
- Manages submissions in concert with other US Regulatory Affairs Managers to facilitate registration and maintenance of products including pharmaceutical small molecules, biopharmaceuticals and bioactive large molecules, generics, health/nutritional products and possibly pesticides.
- Provides consultation and construction of pharmaceutical formulation research, manufacture, and regulatory submissions.
- Supports business development, as needed, through due diligence of acquisition targets as a regulatory CMC expert for the US market
- Participates in Regulatory audits or inspections, as appropriate.
- Participates with pre- and post-approval regulatory affairs in drug experience reporting, changes to labelling and CMC processes and other reporting as required by agencies.
Subject Matter Expert
- Maintains current knowledge of relevant regulations, ensuring that Vetoquinol USA Inc. product development and maintenance complies with regulations of the US and/or global regulatory agencies with a focus on CMC-related concerns.
- Keeps abreast of US and international legislation, guidelines, and customer practices.
- Develops and fosters working relationships with US regulatory agencies and with industry associations
- Provides technical leadership and recommendations to commercial manufacturing and R&D project teams and functions through interpretation of new and emerging US regulatory trends pertinent to the needs of the business
- Implements strategies and/or processes to optimize regulatory performance of CMC activities considering those trends
- Supports the company vision and mission, and demonstrates the corporate core values in all professional activities
- Complies with all OSHA safety requirements, work rules and regulations
- Compiles with and maintains all required paperwork, records, documents, etc.
- Follows systems and procedures outlined in company manuals and policies
- Maintains departmental housekeeping standards
- Completes all other duties as requested by management
- MS, PhD, or DVM degree in Chemistry, Engineering, Pharmaceutical Sciences, Biology, Animal Sciences, Regulatory Affairs, or a related field.
- A minimum of 5 years experience in direct interactions with CMC under any Center of FDA is required; with FDA, CVM, Division of Manufacturing Technologies being ideal
- Experience in cGMP regulated industry is required
- Intimate knowledge of regulations, as well as guidance documents and the ability to conduct submissions/ e-submissions is expected
- Direct experience in animal health pharmaceutical product development is ideal. Additional experience with EMA is highly desirable
- Experience working on dispersed project teams and/ or with contract research organizations(CROs) is highly desirable
- Strong technical and scientific review skills
- Emotional intelligence with a strong risk based decision making background
- Exceptional organizational and time management skills
- Highly developed interpersonal skills, possessing an ability to work with a diverse population
- Ability to function independently in a multi-task environment, as well as part of a team
- Ability to work with international internal and external partners from diverse cultural backgrounds in a matrixed environment
- A desire to lead decision-making in an atmosphere of rapid growth.