Senior Director, Regulatory Strategy

Vertex Pharmaceuticals Inc (US); United States; Hybrid; USD 232,000 - 348,000; Full time

Job summary

Vertex Pharmaceuticals is seeking a Regulatory Strategy Senior Director to lead global/regional regulatory strategies for development programs and marketed products. This hybrid role requires 3 days onsite in Boston or Washington, D.C., with responsibilities spanning advisory, strategy development, and cross-functional leadership.

The role demands extensive regulatory affairs expertise, strong communication, and the ability to influence senior management and cross-functional teams in a matrix

Qualifications

• Business-minded leader with strategic thinking and innovative regulatory solutions.
• Excellent communication skills to influence decisions at all levels and present regulatory strategy plans.
• Ability to provide regulatory leadership on cross-functional teams within a matrix environment.
• Advanced knowledge of global/regional/local regulatory legislation for pharma development.
• Demonstrated expertise in crafting regulatory pathways and interactions with health authorities.

Responsibilities

• Lead development of regulatory strategy for complex development projects from first-in-human to post-marketing.
• Represent GRA on core development teams and align regulatory input with clinical and commercial strategy.
• Advise senior management on status of regulatory strategies and tactics.
• Oversee project plans, timelines and resource allocation to meet key goals on time.
• Influence regulatory environment through participation in conferences and regulatory meetings.

Skills

Strategic thinking

Regulatory leadership

Cross-functional collaboration

Regulatory affairs expertise

Communication skills

Regulatory policy & environment

Analytical skills

People management

Education

Bachelor's degree in Biology, Chemistry or related field

Job description

Job Description The Regulatory Strategy Senior Director is a regulatory leader with expert technical and tactical experience in regulatory strategy for the assigned global or regional position and will be responsible for overseeing the development and implementation of advanced global regulatory strategies for development programs (1) in emerging disease areas, (2) for additional development of registered Vertex medicines, and/or (3) for the support of Vertex marketed products. This incumbent will play a major role in shaping cohesive regulatory strategy across the assigned programs and ensuring effective integration of broad regulatory ideas/tactics supporting franchise strategy. This roles responsibilities may be global, regional or local depending on the position and assigned region. This role will understand and translate regulatory, scientific, operational and business knowledge into effective implementation plans and strategy. This is a hybrid position requiring 3 days/week onsite in our Boston or Washington, D.C office.

Key Duties & Responsibilities:

Leads the development of regulatory strategy for multiple and/or complex projects in development (from first-in-human to post marketing application stage) outlined in Global Regulatory Strategy Documents including for regulatory submission documents and Health Authority communications

Represents GRA on core development teams, project teams, and collaborate with regional leaders and teams to ensure unified regulatory input into clinical programs and commercial strategy

Addresses complex issues, providing advanced regulatory solutions and guidance to cross-functional teams and align communication to and from cross-functional teams and GRA leadership.

Counsels and advises senior management on status of global Regulatory Affairs strategies and tactics, procedures and practices

Leads the development and management of project plans and timelines and assigns and manages resources effectively to ensure all projects are appropriately prioritized and key goals are met on time

Works to influence regulatory environment through active participation in conferences and industry/agency regulatory meeting, committees and trade associations.

Remains up to date on changing regulations, and regulatory policy and intelligence including competitive issues that influence regulatory strategy.

Leads continuous improvement efforts on existing department processes and strategies, providing recommendations in area of expertise

Leads GRA functional team(s) including participating in the skill development, coaching, and performance feedback for members of the GRA functional teams

As a people manager within the organization, may have financial accountabilities and human resource responsibilities for assigned staff.

Required Knowledge & Skills:

A business-minded leader, capable of strategic thinking and proposing innovative solutions to regulatory problems

Demonstrates excellent communication skills with ability to impact and influence the decisions of a team, communicates with all levels within the company and act as liaison / representative both internally and externally and communicates effectively in verbal presentations and in writing regulatory strategy plans and submission documents

Able to provide regulatory leadership on a cross-functional team and work effectively in a matrix environment

Demonstrated technical expertise in regulatory affairs science including advanced knowledge of regulatory frameworks and external environments.

Expert knowledge of global/regional/local regulatory legislation, laws, procedure and guidance for pharmaceutical development of medicines for human use, with demonstrated knowledge of the research and development, preclinical and clinical requirements related to drug development, registration, and maintenance of human pharmaceuticals

Advanced proficiency in analyzing and interpreting data, protocols, safety reporting, labeling and other activities related to the phases of drug development for assigned products.

Demonstrated expertise in creating and assessing proposals to regulatory authorities on regulatory paths and clinical plans, and in leading productive health authority interactions, including well organized preparation of cross functional teams.

Demonstrated expertise in analyzing the adequacy of proposed regulatory pathways and strategies and guiding development teams with recommendations for changes/refinements based on ongoing regulatory outcomes throughout development.

Ability to articulate the organization’s strategic vision and core values, and successfully contribute to improving the quality of internal regulatory policies, programs and initiatives.

A strong leader who demonstrates sensitivity and understanding of cultural considerations, embraces diversity, and continuously develops staff by providing feedback, coaching, guidance and mentoring.

Required Education & Experience:

Bachelor's degree in Biology, Chemistry, or other related discipline Typically requires 12 years of relevant pharmaceutical or biotech industry experience within regulatory affairs and 5 years of supervisory/management experience, or the equivalent combination of education and experience #LI-EE1 #LI-Hybrid

Pay Range:

$232,000 - $348,000 Disclosure Statement: The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. 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. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law. 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.

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;
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 [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.