Sr. Manager, Regulatory Affairs CMC

Role Summary

The Sr. Manager, Regulatory Affairs CMC will oversee and execute drug-device combination product regulatory CMC strategy and documentation, provide support to Product Development and Quality Teams for CMC documentation, product and process changes, non-conformances and deviations and associated investigations, and manage regulatory submissions for new products and changes to marketed products. The role will provide strategic guidance to project teams to ensure regulatory compliance and offer actionable solutions for regulatory challenges.

Responsibilities

• Develop regulatory CMC strategy in collaboration with project team for drug-device combination products including authoring and review of regulatory submissions (INDs, NDAs, DMFs, etc) and review of Product, Manufacturing, and Quality documentation (specifications, product development reports and protocols, NCRs, CAPAs, etc.)
• Support labeling generation, updates, and implementation for both new product development and updates to approved labeling documentation, including Prescribing Information, Instructions for Use, and applicable printed components of product packaging.
• Participate in and/or lead development of CMC related change controls. Evaluate regulatory and quality documentation impact of post-approval changes to product, process, materials, etc. and serve as Regulatory expert in developing plans for implementation of planned changes, including management and preparation of required regulatory submissions
• Manage preparation and submission of periodic reports, including annual reports to regulatory bodies, as applicable.
• In collaboration with Regulatory and Quality Management, manage process for field action reporting, product recall, and associated actions and communications if product is determined to not meet quality requirements
• Identify and implement improvements in CMC-related procedures and processes to enhance efficiency and maintain compliance with evolving regulatory requirements

Qualifications

• Required: Bachelors in a relevant scientific discipline (Chemistry, Chemical Engineering, Pharmaceutical Development, etc.) with a minimum of 7-10 years’ experience in Product development and manufacturing, CMC, Regulatory, or Quality. Advanced degree in a related scientific field and/or cross-functional experience preferred.
• Required: Expertise in CMC-related regulatory requirements, FDA guidances, and associated standards. Experience with drug-device combination products preferred.
• Required: Expertise in preparation and review of regulatory submission documentation, including US and ex-US meeting documents, INDs/CTAs, NDAs/MAAs, etc.
• Required: Knowledgeable in post-approval product and manufacturing change assessments for drug-device combination products
• Required: Knowledgeable of good manufacturing practices, good documentation practices
• Required: Knowledge of project management tools and techniques to ensure timely and effective completion of multidisciplinary deliverables

Skills

• Teamwork & Leadership: Cross functional influencer and network builder; attunes roles, responsibilities and expectations of x-functional teams and stakeholders to cultivate innovation and deliver results; mentors/guides diverse stakeholders.
• Execution: Consistently directs, drives and holds others accountable for cross-functional results; identifies ambiguity and a path forward; removes obstacles to facilitate work.
• Solution Maker: With strategic mindset, distills complex and ambiguous information and leverages teams and internal/external networks to deliver x-functional solutions; role models approach and inspires others to create solution.
• Continuous Improvement: Create new and better ways for x-functional teams to be successful; develops and leverages strengths of individuals and teams; and inspires others to anticipate problems and plan for success; seeks new ways to learn and be challenged.
• Awareness: Leverages awareness and recognition of the strengths and limitations of others; resolves ambiguity and helps others reframe questions to optimize ideas and solutions.

Education

• Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Development, or a related scientific field (minimum 7–10 years of experience in Product development/CMC/Regulatory/Quality)
• Advanced degree in a related scientific field and/or cross-functional experience preferred

Additional Requirements

• Travel to vendor facilities such as manufacturing sites periodically to observe manufacturing processes, coordinate and manage investigations, support audits, etc. Up to 20% travel time.