Associate Director of Regulatory Affairs
St. Louis, MO, USA
Job Description
Posted Monday, May 20, 2024 at 4:00 AM
Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.
Ready to work with purpose? Look no further, we are hiring for an Associate Director of Regulatory Affairs at our St. Louis Site!
Role Summary
Experienced CMC professional serving as project leader responsible for the development of initial CMC regulatory strategies, submissions and compliance activities for development programs and commercial products supporting the Business Unit with little to no supervision.
This individual will provide and drive strategic and operational global CMC regulatory direction and documentation for assigned projects/products covering initial registrations and approval/post approval activities. Leads the initial preparation of CMC information for submission to global regulatory agencies, generates and drives CMC strategies, assesses risks and develops contingency/mitigation plans. Acts as the global CMC representative within cross-functional project teams, involving the interpretation of regulations and guidelines and the assessment of global implications for strategic CMC decisions with little to no supervision.
Accountable for assigned CMC programs, managing daily delivery of regulatory and strategic activities, including post-approval changes, portfolio growth initiatives, and ongoing compliance of commercial products in the portfolio. May represent CMC during interactions with regulatory agencies and external partners either directly or in conjunction with Regulatory Affairs.
Qualifications
- The colleague will have BS/MS/PhD or equivalent scientific/engineering/pharmaceutical development sciences degree.
- Must have a minimum of 5-7 years relevant pharmaceutical development, QA/QC, and/or manufacturing experience.
- Must have a minimum of 4 years drug substance or drug product development or manufacturing technical support experience.
- Experience with diverse dosage forms, particularly sterile combination products, is desirable.
- Experienced in regulatory CMC professional or an individual with regulatory expertise in pharmaceutical science development or manufacturing and/or specific regulatory domain. Ability to interpret and apply global/regional CMC regulatory policies and requirements for assigned portfolio.
- Sound understanding and functional knowledge of manufacturing/pharmaceutical sciences/the pharmaceutical industry with a clear understanding of drug development/commercial manufacturing of pharmaceutical products, including technical and scientific understanding of pharmaceutical drug development with technical writing skills. Competent working knowledge of computer-based systems such as Microsoft Office, controlled documentation systems (e.g. Documentum). Ability to learn and navigate tracking/change control systems, compliant and consistent use of systems (including GMP validated systems) and willingness to train and support others in system use.
- Clear track record of effective teamwork, collaboration, and communication, and also demonstrated leadership ability in a cross-functional matrix team environment. Product management along with planning/organizing by prioritizing and planning work activities and change agility are also essential attributes.
Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.
Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.
Equal Opportunity Employer:
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.
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