Chemistry Manufacturing Controls Manager

Vertex Pharmaceuticals • Boston, MA

261d • $122,600 - $183,900

About The Position

The Regulatory Affairs Chemistry Manufacturing Controls (CMC) Manager will influence the execution of multi-product global regulatory CMC strategies for investigational and marketed products. The scope of this role includes leading and managing a specific product's life cycle including post approval variations and line extensions within approved markets and global expansion in new markets. This role contributes to the preparation and submission of regulatory CMC documentation and interactions with Health Authorities for CMC topics. This role also provides regulatory support and guidance to various cross-functional teams to ensure all applicable global regulatory requirements are considered and appropriately incorporated into the life cycle of investigational and commercial programs.

Requirements

• Strong interpersonal skills to exchange complex information with others and to guide others
• Proficiency in global regulatory guidelines (FDA, EMA, Health Canada and ICH)
• Experience in the preparation, including writing, of CMC submissions
• Strategic thinking and strong problem solving skills
• Ability to collaborate and communicate in an open, clear, complete, timely and consistent manner
• Strong sense of planning and prioritization, and the ability to work with all levels of management
• Capable of strategic thinking with ability to resolve complex and ambiguous situations
• Sound knowledge of cGMP, FDA, EMA, ICH
• Experience using the Veeva Vault Regulatory Information Management System (RIM)

Responsibilities

• Lead team to author, review and approve CMC sections of regulatory submissions, as well as the interactions and responses with regulatory agencies
• Contributes to the development of global regulatory CMC strategies for investigational and/or commercial products
• Provides regulatory CMC guidance to cross-functional teams and key stakeholders
• Influences regulatory assessment and guidance on product compliance topics including change controls, deviations, and GMP investigations
• Participates effectively on cross-functional teams and serve as the global regulatory CMC lead for assigned products and projects

Benefits

• Medical, dental and vision benefits
• Generous paid time off including a week-long company shutdown in the Summer and the Winter
• Educational assistance programs including student loan repayment
• Generous commuting subsidy
• Matching charitable donations
• 401(k)
• Annual bonus and annual equity awards

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree