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Associate Director, Regulatory Strategy

Semma Therapeutics

Semma Therapeutics

Boston, MA, USA
Posted on Friday, May 31, 2024

Job Description

The Regulatory Strategy Associate Director will be responsible for overseeing the development of regional or global regulatory strategy for development programs or marketed products. This role will serve as a global regulatory lead, or in some cases a regional regulatory lead, for development and/or commercial product(s) within the Vertex portfolio and contribute to the global regulatory strategy for the assigned program(s). This role requires advanced understanding of regulatory affairs frameworks in the US, Europe, or other international markets, drug development, and related concepts, and the ability to translate this knowledge into effective regulatory planning and strategy development.

Key Duties and Responsibilities:

  • Leads the development and implementation of global regulatory strategy for assigned projects in development through commercial stages

  • Contributes to and may lead the development and implementation of regional regulatory strategy to inform the global strategy for certain projects

  • Leads regulatory communications and interactions with health authorities

  • Advises teams on regulatory requirements for development and approval pathways, including potential for expedited pathways

  • Leads and oversees the process for preparation, submission, and approval of regulatory applications

  • 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

  • Advises cross-functional teams and senior management on regulatory risks, considerations, and strategies for program(s)

  • Acts as an advisor and coach to mentor members of the team

Knowledge and Skills:

  • Specialized knowledge of global and regional regulatory affairs frameworks and guidelines

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

  • Comprehensive understanding of requirements and processes to maintain a product on the market, product labeling, 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, tailored to multiple audiences, to communicate difficult concepts and persuade others to adopt a different point of view

  • Ability to effectively lead and work within a team environment

  • Prior experience with major health authority submissions and health authority interactions is required.

Education and Experience:

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

  • Typically requires 8 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-Hybrid #LI-AR1

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