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Senior Manager, Regulatory Strategy

Semma Therapeutics

Semma Therapeutics

Legal
Boston, MA, USA
Posted on Tuesday, July 2, 2024

Job Description

The Regulatory Strategy Senior Manager will be responsible for contributing regional or global regulatory strategy expertise for development programs or marketed products. The Regulatory Strategy Senior Manager will serve as a regional regulatory lead, or in some cases may also be a global regulatory lead, for development and/or commercial product(s) within the Vertex portfolio. This role requires understanding of regulatory affairs frameworks in the US, Europe, or other international markets, and understanding of drug development and related concepts.

Key Duties and Responsibilities:

  • Leads the development and implementation of regulatory strategy for assigned region as a member of the global regulatory affairs functional team

  • Contributes to and may lead global regulatory strategy development for certain programs

  • Responsible for regulatory communications with local health authority; may independently lead regulatory interactions with the health authority

  • Provides guidance to teams on regulatory requirements for development and approval pathways for assigned region, including potential for expedited pathways

  • Manages the process for preparation, submission, and approval of regulatory applications within assigned region

  • Provides strategic and technical regulatory input for key product development or registration documents

  • Ensures compliance of regulatory submissions with current regulations and guidance

  • Reviews and evaluates regulatory intelligence and guidance information to continuously inform regulatory strategy in assigned region

Knowledge and Skills:

  • In-depth knowledge of global and regional regulatory affairs frameworks

  • Good understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology

  • Good understanding of requirements and processes to maintain a product on the market; reporting and surveillance

  • Ability to assess and understand complex scientific information, regulatory precedent, competitive intelligence, and regulatory guidelines and make recommendations based on assessment

  • Strong problem-solving skills

  • Strong written and verbal communication skills to explain difficult information and build alignment

  • Ability to work effectively within a team environment

  • Ability to plan, prioritize, and execute work and projects in a systematic and efficient manner

Education and Experience:

  • Bachelor's degree in Biology, Chemistry, or other related discipline

  • Typically requires 6 years of relevant pharmaceutical or biotech industry experience within regulatory affairs, or the equivalent combination of education and experience

We’re enabling flexibility and choice between individuals and their managers to maintain our strong culture of collaboration and ensure a daily vibrancy within our sites globally. In this Hybrid or On-Site-Eligible role, you can choose to work:

1. Hybrid and work remotely up to two days per week; or select

2. On-Site and work 5 days per week with ad hoc flexibility.

#LI-AR1 #LI-Hybrid

Flex Designation:

Hybrid-Eligible Or On-Site Eligible

Flex Eligibility Status:

In this Hybrid-Eligible role, you can choose to be designated as:
1. Hybrid: work remotely up to two days per week; or select
2. On-Site: work five days per week on-site with ad hoc flexibility.

Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.

Company Information

Vertex is a global biotechnology company that invests in scientific innovation.

Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.

Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at ApplicationAssistance@vrtx.com