Regulatory Strategy Manager

Vertex UK Int'l HQ/R&D; Boston (MA); Hybrid; GBP 120,000 - 170,000; Full time

Job summary

Vertex UK Int'l HQ/R&D is seeking a Regulatory Strategy Senior Manager to lead regional regulatory strategy for development programs and marketed products. The role covers regional/or global responsibilities within the Vertex portfolio, with emphasis on US, Europe, and international markets.

The candidate should understand regulatory affairs frameworks, drug development concepts, and have a track record in interactions with health authorities.

Qualifications

• In-depth knowledge of global and regional regulatory affairs frameworks.
• Good understanding of drug development concepts including clinical trial design and pharmacology.
• Experience with regulatory submissions, health authority interactions, and post-market surveillance.

Responsibilities

• Leads development and implementation of regulatory strategy for assigned region as a member of the global regulatory affairs team.
• Contributes to and may lead global regulatory strategy development for certain programs.
• Responsible for regulatory communications with local health authorities and may lead interactions.
• Guides teams on regulatory requirements for development and approval pathways for the region.
• Manages preparation, submission, and approval of regulatory applications within the region.
• Provides regulatory input for key product development or registration documents.
• Ensures submissions comply with current regulations and guidance.
• Reviews regulatory intelligence to inform strategy in the assigned region.

Skills

Regulatory affairs knowledge

Drug development understanding

Regulatory communications

Team collaboration

Problem solving

Written and verbal communication

Education

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

Job description

Job Description General Summary

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

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. #LI-Hybrid

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 [e-mail]

Help Us Achieve Our Mission Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and conditions. The company has approved therapies for cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, acute pain and acromegaly, and it continues to advance clinical and research programs in these areas. Vertex also has a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where it has deep insight into causal human biology, including IgA nephropathy, neuropathic pain, APOL1-mediated kidney disease, primary membranous nephropathy, congenital adrenal hyperplasia, ACTH-dependent Cushing's syndrome, autosomal dominant polycystic kidney disease, type 1 diabetes, generalized myasthenia gravis, and myotonic dystrophy type 1.

Vertex was founded in 1989 and has its global headquarters in Boston, with international headquarters in London. Additionally, the company has research and development sites and commercial offices in North America, Europe, Australia, Latin America and the Middle East.

Vertex is consistently recognized as one of the industry's top places to work, including 16 consecutive years on Science magazine's Top Employers list and one of Fortune’s 100 Best Companies to Work For. For company updates and to learn more about Vertex's history of innovation, visit www.vrtx.com or follow us on LinkedIn, Facebook, Instagram, YouTube, and X

We believe our culture is one of Vertex’s greatest strengths and a key enabler of our ability to deliver transformative medicines for patients who need them. Rooted in innovation, purpose and collaboration, our culture empowers people to take smart risks, challenge conventional thinking and do their best work. The diversity of our people is central to that culture. By bringing together individuals with different backgrounds, experiences and perspectives, we foster an environment where new ideas thrive, better decisions are made and breakthrough innovation is possible. We are committed to creating a workplace where everyone feels valued, included and connected to our shared mission, because we know that our unique culture and the collective strength of our people are what set Vertex apart.