Director, Regulatory Affairs Business Operations (Boston, MA) page is loaded Director, Regulatory Affairs Business Operations (Boston, MA) Apply locations Boston, MA time type Full time posted on Posted 8 Days Ago job requisition id REQ-21405
Job Description
General Summary:
The Regulatory Affairs Business Operations Director leads the overall management of the Global Regulatory Affairs (GRA) resource plans and budget. This position will report directly to the Senior Director of Regulatory Compliance and Business Operations.
Key Duties and Responsibilities:
- Provide oversight and maintain accurate assessment of all aspects of resource management for GRA full-time employees and temporary headcount (independent contractors, FSP staff) including open, approved and filled positions
- Lead resource planning/headcount/capacity forums for individual functions, as appropriate
- Provide oversight and maintain an accurate assessment of current and projected resource demand
- Develop processes that drive efficiency for resource planning
- Partner with key corporate stakeholders (i.e. Finance, HR) to provide central Global Regulatory Affairs oversight of the global cycles, such as long-range planning (LRP), AOP/Budget, and workforce planning for Global Regulatory Affairs to ensure spend and resource decisions are in line with strategic functional goals
- Develop, maintain and manage a continuous process for measuring and reporting on financial and workforce planning activities keeping leadership and other stakeholders informed of progress
- Engage GRA Leaders provide stakeholder input to develop strategy for resource planning for each functional area
- Lead collaboration with GRA Leaders, HR, and Finance in workforce planning, long-range planning, and budgeting activities to meet needs of dynamic portfolio and ongoing resource/capacity needs
- Facilitate ongoing meetings with HR and Finance regarding headcount forecasting and budget management
Knowledge and Skills:
- Experience managing financial and workforce planning activities, including financial reporting and analysis, and in-depth knowledge of Regulatory Affairs and/or Drug Development Lifecycle
- Experience with corporate planning cycles, including annual Budgets, Long-Range planning, and Workforce Planning.
- Demonstrated attention to detail, accuracy, and excellent analytical and problem-solving skills in a fast-paced environment.
- Results-oriented
- Excellent leadership and interpersonal skills with an ability to effectively work and problem solve within a multidisciplinary team
- Excellent verbal and written communication and presentation skills
Education and Experience:
- Typically requires a Bachelor's degree in Life Sciences or Business Administration
- Typically requires 10 years of experience in the biopharmaceutical industry 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.
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 .
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Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases. The company has approved medicines that treat the underlying causes of multiple chronic, life-shortening genetic diseases - cystic fibrosis, sickle cell disease and transfusion-dependent beta thalassemia - and continues to advance clinical and research programs in these diseases. 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 APOL1-mediated kidney disease, acute and neuropathic pain, type 1 diabetes, myotonic dystrophy type 1 and alpha-1 antitrypsin deficiency .
Founded in 1989 in Cambridge, Mass., Vertex's global headquarters is now located in Boston's Innovation District and its international headquarters is 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 14 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 or follow us on Facebook , Twitter/X , LinkedIn , YouTube and Instagram .
The diversity and authenticity of our people is part of what makes Vertex unique, and we recognize that each employee brings diverse perspectives and strengths. By embracing those strengths and celebrating differences, we are fostering an inclusive culture where each of us can bring our authentic selves to work, inspire innovation together, and change people's lives.
Our vision is clear: to be the place where an authentic, diverse mix of talent want to come, to stay, and do their best work.