Regulatory Strategy Manager

Vertex Inc. • Boston, MA

3d • $124,000 - $186,000 • Hybrid

About The Position

The Regulatory Strategy Manager will be responsible for regulatory support for development programs or marketed products. The Regulatory Strategy Manager will contribute to the development of US regional or global regulatory strategies for development and commercialization of program(s) within the portfolio. This role requires a good understanding of regulatory affairs frameworks, the drug development process, and related concepts.

Requirements

• Good knowledge of regional regulatory affairs frameworks
• Understanding of requirements and processes to maintain a product on the market; reporting and surveillance
• Understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology
• Ability to assess and understand complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines
• Strong problem-solving skills
• Strong written and verbal communication skills to exchange complex information with others in complex situations
• Ability to work effectively within a team environment
• Ability to plan, prioritize, and contribute to work and projects in a systematic and efficient manner
• Bachelor's degree in Biology, Chemistry, or other related discipline
• Typically requires 4 years of relevant pharmaceutical or biotech industry experience or the equivalent combination of education and experience

Responsibilities

• Contributes to the development and implementation of regulatory strategy for assigned region as a member of the global regulatory affairs functional team
• Develops proficiency in regional and global regulatory skills
• Supports global regulatory strategy under guidance of the Global Regulatory Lead
• Responsible for regulatory communications with local health authority; under supervision, may lead regulatory interactions with the health authority
• Identifies regulatory requirements for development and approval pathways for assigned region
• Under supervision, manages the process for preparation, submission, and approval of regulatory applications within assigned region
• Provides technical regulatory input for key product development or registration documents
• Works to ensure compliance of regulatory submissions with current regulations and guidance
• Reviews regulatory intelligence and guidance information to continuously support regulatory strategy in assigned region

Benefits

• This role is eligible for an annual bonus and annual equity awards.
• Some roles may also be eligible for overtime pay, in accordance with federal and state requirements.
• At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations.
• From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager