Search using our robust engine. Get the recommendations you need to get ahead.
Browse through our expansive list of legal practice areas.
Work where you are or where you would like to be. Find where you will work with LawCrossing.
Use our marketplace to feature your opportunity
Start your search today
Set up your account and manage your company profile on LawCrossing
Look through and compare company profiles
Learn from the legal expert
Discover salaries and the scope of your next job
LawCrossing Works Read Testimonials and Share your Story
Carrot Peelers, Sales, Personality and Your Job Search
In-House
Attorney
Corporate
Litigation - Whistleblower - CFTC
Min 5 yrs required
Manager, Regulatory Affairs CMC, Combination Products and Medical Devices The candidate will identifies and collects data needed and prepares CMC regulatory product strategies under limited supervision and seeks expert advice and technical support as required for strategies and submissions. Will prepares regulatory submission documentation, including new applications and amendments, renewals, annual reports, supplements and variations under limited supervision and manages products and change control in compliance with regulations and company policies and procedures. Develops strategies for CMC meetings, manage preparation for agency meetings and manages content of pre-meeting submissions and regularly informs regulatory management of important timely issues. Trains, develops and mentors individuals; may include formal supervisory responsibilities and develops and implements policies and procedures within the regulatory affairs department. Analyzes legislation, regulation and guidance and provides analysis to the organization and represents CMC regulatory affairs on teams such as the product development, Global Regulatory Product Teams and Operations brand teams, for assigned projects; negotiates with and influences team members to maximize chances for first pass approval or regulatory submissions. Support combination products and medical devices including design control and change management activities.
Qualification and Experience
The candidate must have a Bachelor's degree (or equivalent); Bachelor's degree in science (biology, chemistry, microbiology, immunology, medical technology, pharmacy, pharmacology), math, or engineering and relevant advanced degree is preferred (MS, PhD, JD degree). Must have 5+ years of experience in a regulated industry (pharmaceutical and/or medical device products) and 3-5 years in quality systems or cross-functional project management. Must preferably have 5+ years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area and 3-5 years of experience at a regulatory agency, such as FDA, EMA or other national agency or experience at a Notified Body. Certification is a plus (e.g. RAC from the Regulatory Affairs Professionals Society.) Strong CMC, Medical Device or other regulatory knowledge is preferred.
Ref: 15000003O3
Sign Up Now