Job Description
General Summary :
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.
Associate Director, Global Regulatory Strategy, Oncology
Serve as the global regulatory lead delegate for development compounds in the oncology portfolio, responsible for setting global regulatory strategy with the GRL, representing regulatory on the development core teams, and leading the Global Regulatory Sub-teams with support from the GRL. Moderna The...
Associate Director, US Regulatory, Advertising & Promotion
Associate Director, US Regulatory, Advertising & Promotion. Associate Director, US Regulatory, Advertising & Promotion (Hybrid Working Model). The Associate Director, Commercial Regulatory Affairs will report to the Sr. This position requires frequent interaction and strong collaboration wit...
Director, Regulatory Affairs - Small Molecule Strategy
The Associate Director of regulatory Affairs will be responsible for the development and execution of the Regulatory strategy for assigned programs in alignment with the corporate goals. Monte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team a...
Associate Director Regulatory Affairs CMC
Leads development and execution of robust global regulatory CMC strategy for assigned program(s) with balanced risk-based approach using scientific rationale and in alignment with regulatory guidance, working in collaboration with cross-functional CMC and Global Regulatory Teams to achieve program a...
Strategy Development, Associate Director
The Associate Director of Strategy Development will facilitate the strategy in developing and executing innovation and corporate growth through partnerships/alliances, acquisitions, mergers and joint ventures. CK Science are seeking a Strategy Development, Associate Director on a full time basis bas...
Director, Global Regulatory Affairs, Development Strategy
Director, Global Regulatory Affairs, Development Strategy. Developing and implementing US regulatory development strategy leading to successful registration and life-cycle management of unique and technologically complex products serving patients with rare diseases and unmet medical needs. Providing...
Associate Director, Strategy & Execution- US Rare Disease
The Associate Director, Strategy & Execution will support the US Rare Disease Franchise to ensure that the franchise is best positioned to deliver on its strategy and business priorities. Reporting to the Director of Strategy & Execution - US Rare Disease, this individual will have two prima...
Associate Director, Global Regulatory Affairs CMC
The Associate Director of Global Regulatory Affairs Chemistry, Manufacturing, and Controls (GRA-CMC) will be responsible for leading and providing global CMC regulatory support for the clinical and commercial product portfolio. Partner with representatives of Regulatory Affairs including in-country ...
Strategy Development, Associate Director
The Associate Director of Strategy Development will facilitate the strategy in developing and executing innovation and corporate growth through partnerships/alliances, acquisitions, mergers and joint ventures. Strategy Development, Associate Director. CK Science are seeking a Strategy Development, A...
Associate Director, Influencer Strategy
The Associate Director of Influencer Strategy will play a pivotal role in crafting outcome-driven strategies and industry best practices for our customers and prospective customers seeking to use Later, enabling the company to unlock revenue impact from those accounts. This individual will collabora...