Assistant or Associate Director, Regulatory Affairs- Medical Device/CMC
Position can be located in either the St. Louis, Missouri office or their Clearwater, Florida office
relocation is provided
Candidate MUST have Medical Device experience and must have written CMC submissions in the past (recent past is preferred)
Individual Contributor role
Specialty and Diverse Pharmaceutical company is adding to their high profile team
competitive base salary, plus bonus, full benefits and other Long Term Incentives...
Please submit resume and a few sentences describing your relevant experience
independently manages all regulatory CMC post-approval aspects of company's Pharmaceuticals medical device products. This includes assessing manufacturing changes for regulatory impact, coordinating development of regulatory strategies for regulatory submissions in support of the manufacturing changes and authoring the necessary post approval submissions including annual reports and memoranda to technical files. The Associate Director manages interactions with regulatory authorities on CMC issues.
Formulate, lead and drive post-approval CMC regulatory strategy for marketed products with input from Product Lead as needed.
Provide input into CMC regulatory strategy for development products working closely with the Product Lead.
Proactively communicate CMC regulatory strategy, key issues and any other critical topics throughout the life cycle to interdisciplinary project teams and to appropriate management level in Regulatory Affairs, R&D, TechOps and Supply Chain as appropriate in an a timely manner.
Lead and drive all post-approval CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. Make quality regulatory decisions, balancing regulatory compliance risks and business benefits.
Identify as early as possible, the required documentation and any content, quality and/or timeline for post-approval submissions. Negotiate the delivery of approved technical source documents in accordance with project timeline.
Coordinate with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities.
Manage interactions with Health Authorities on CMC issues.
Provide regulatory support to other company functions during Regulatory Authority inspections.
Serve as Regulatory Affairs representative on facility/site Local Change Management Boards.
Participate in assigned due diligent business activities.
Review and provide input on proposed health authority guidance documents on CMC issues.
Knowledge of development and life-cycle management support of medical devices and combination products. and Knowledge of current and emerging issues and trends of the medical device regulatory environment.
Ability to influence external regulatory stakeholders and shape the external regulatory environment and ability to interpret Regulatory Authority policies and CMC guidance and correctly apply them as appropriate in product development and post-approval activities.
Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data and Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.
Self-motivated, detail-oriented and capable of working independently, Strong business acumen and ability to see the business drivers outside of Regulatory Affairs.
REQUIREMENTS: 10+ years pharmaceutical industry and 8+ relevant regulatory CMC experience with at least 3+ years specific experience in supporting medical devices.
-CMC submission experience with Class I, II and III medical devices in US and Class IIa & IIb in EU and working knowledge of Technical Files.
-Bachelor’s degree in science, bio-chemical engineering, pharmacy or other health related field.
-Advanced degree highly preferred ( MS, Pharm.D, Ph.D. or equivalent)