Senior Regulatory CMC Strategy Manager
Location
United Kingdom
Posted
1 day ago
Salary
0
Seniority
Senior
Job Description
Senior Regulatory CMC Strategy Manager
ICON plc
• Defining, coordinating and implementing global CMC regulatory strategies for product specific development and life-cycle activities • Providing proactive strategic guidance to the product-specific global regulatory and manufacturing sub-teams for defining global regulatory CMC strategies and objectives pertaining to the development, registration, commercialization and lifecycle management of the drug product in the United States and international markets • Liaising directly with the US FDA and with local regulatory teams for discussions with international health authorities and agencies for CMC-related matters • Negotiating with regulatory authorities during the development process to ensure submission acceptance and approval • Managing the CMC regulatory strategy of high quality and compliant regulatory CMC documentation (e.g., BLAs, INDs, CTAs, MAAs, Variations/Supplements and other relevant regulatory filings such as meeting requests and briefing packages) for the assigned product(s) within defined timelines as per R&D and business objectives • Advising on regulatory strategies, solutions to scientific problems and interpretation of results in the context of product registration requirements combined with business needs and goals • Facilitating the communication and flow of regulatory information (regulatory framework, scope and project timelines) to all relevant stakeholders • Identifying and recommending the most effective CMC regulatory strategies to assure a first-pass regulatory approval of initial application and lifecycle supplements/variations • Collaborating with key functions in the preparation, review and approval of regulatory CMC submissions as assigned to product and programs • In collaboration with the network strategist, developing and managing timelines supporting regulatory submissions, proactively identifying risks and developing adequate risk management solutions in consultation with cross-functional teams
Job Requirements
- Bachelor's degree in a relevant scientific discipline or healthcare-related field
- Extensive experience in global pharmaceutical/biotechnological drug development and proven knowledge of the global regulatory CMC environment
- Demonstrated experience in authoring and managing components of regulatory submissions
- Good knowledge of global regulatory requirements and demonstrated ability to function as the lead interface with FDA
- Ability to support regional and local regulatory affairs teams for interactions with regional or local health authorities (e.g., EMA, PEI, AGES, PMDA, Health Canada, etc.)
- Demonstrated ability to develop and implement global CMC regulatory strategies, resolve complex issues, and negotiate optimal regulatory pathways and outcomes with health authorities.
Benefits
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways
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