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About this role
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.
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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
At Vertex, we embrace continuous learning and encourage employees to stay informed on advances in AI, technology, automation, and industry trends. We seek talent who bring an external perspective, demonstrate curiosity and sound judgment, and thoughtfully adopt new capabilities that improve decision-making, drive innovation, increase efficiency, and help deliver better outcomes for patients.
Flex Designation:
Hybrid-Eligible Or On-Site Eligible
Flex Eligibility Status:
In this Hybrid-Eligible role, you can choose to be designated as:
Hybrid: work remotely up to two days per week; or select
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 ApplicationAssistance@vrtx.com
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 17 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*](https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.vrtx.com&esheet=52609949&newsitemid=20220321005939&lan=en-US&anchor=www.vrtx.com&index=2&md5=a32693d2c9354cbbd5ad1e43dab9dd40) *or follow us on* [*LinkedIn*](https://www.linkedin.com/company/Vertex-Pharmaceuticals)*,* [*Facebook*](https://www.facebook.com/VertexPharmaInc)*,* [*Instagram*](https://www.instagram.com/vertexpharmaceuticals)*,* [*YouTube*](https://www.youtube.com/@Vertex-Pharmaceuticals)*, and* [*X*](https://x.com/VertexPharma)
*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.*
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