Global Regulatory Strategy Director
Discover International
Discover International is seeking an experienced Global Regulatory Affairs leader to own regulatory strategy across development and post-marketing programs. You will lead interactions with health authorities, align regional plans, and coach a matrixed team of regulatory professionals to drive timely submissions and informed business decisions. The ideal candidate brings 12+ years in regulatory affairs, including 5+ years of management, and a deep knowledge of global and regional regulations #J-18808-Ljbffr
- Arbor Biotechnologies is seeking a Director of Regulatory Affairs to lead regulatory strategy across its portfolio, spanning preclinical and early clinical programs. You will serve as the global regulatory lead and primary contact with FDA and other authorities, guiding...Suggested
- AstraZeneca in Cambridge, MA is seeking a Regulatory Affairs Director to provide strategic and operational regulatory leadership across oncology programs. The role spans global/regional leadership, drafting strategy, and engagement with health authorities. The RAD will...Suggested
- GSK seeks an experienced Director of Global Regulatory Strategy to lead regulatory planning for Respiratory, Immunology and Inflammation assets. You will shape development programmes, coordinate with global teams and drive regulatory submissions with health authorities...Suggested
- Takeda is seeking an Associate Director of Global Regulatory Strategy in Cambridge, MA for a hybrid, full-time role. You will lead global regulatory strategies across complex programs and serve as the primary interface with health authorities, including FDA meetings. The...SuggestedFull time
- AstraZeneca seeks a seasoned Regulatory Leader to guide strategic regulatory activities across development, launch, and... ...You will influence authorities and collaborate with global teams to shape regulatory strategies and compliance. With 6+ years in regulatory affairs,...SuggestedLocal area
- ...Discover International seeks a Director of Global Regulatory Affairs for its oncology portfolio. You will own global regulatory strategy from development through approval and label expansion, serving as the regulatory voice in cross-functional teams and leading interactions...
- ...A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing... ...strong communication and leadership skills. This role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr...
- GlaxoSmithKline is seeking a Director of Global Regulatory Strategy- Oncology in a hybrid US role. You will lead regulatory strategies for oncology assets, interact with health authorities, and coordinate cross-functional teams to align with development plans and data...
- Takeda is seeking a seasoned Regulatory Project Manager in Boston to co-lead Global Regulatory Team meetings and cross-functional SWGs, driving regulatory submissions per strategy. You will align operations with GPT goals, supervise timelines, and oversee vendor-delivered...
- AstraZeneca is seeking a strategic Regulatory Leader to guide development, commercialization... ...of assigned products. You will apply global regulatory trends, influence authorities... ...development and leadership, with an emphasis on strategy, risk management, and navigational...Work at office
- Takeda Pharmaceutical Co. in Cambridge, MA, seeks an Associate Director to define and lead global regulatory strategies for complex programs, oversee FDA interactions, and guide cross-functional teams toward compliant, timely submissions. This hybrid role requires an advanced...
$116k - $145k
...Participates in clinical and nonclinical regulatory strategic discussions, supports multiple... ...the implementation of regulatory strategy for assigned markets & provides regulatory... ...submissionsProvides regulatory support to Global Regulatory Lead in definition & communication...Full timeWork at officeRemote work$177k - $278.08k
...the boundaries of what is possible in order to bring life-changing therapies to patients worldwide.Join Takeda as Director, Global Regulatory Labeling Strategy where you will be responsible for the development and implementation of labeling content and strategy of...Minimum wageLocal areaRemote workWorldwide$196.7k - $353.4k
...The Role: Moderna Therapeutics is seeking a Sr. Director of Regulatory Strategy to support oncology programs to be based in its Cambridge headquarters... ..., will be relied on to articulate clear and compelling global regulatory strategies, highlighting risks and...Permanent employmentWork at officeWork from home$200k - $265k
...opportunity to gain new and challenging work experiences and create an unparalleled, direct impact.The OpportunityLeads the global regulatory strategy, submission planning, and health authority engagement for Nemolizumab across all approved and development-stage...Full timeTemporary workWork experience placementWork at officeWorldwide$270k - $380k
...an unparalleled, direct impact. The Opportunity Leads the strategy and drive the registration and maintenance of Galderma's Therapeutic Dermatology (TD) portfolio in accordance with global regulatory requirements and international quality standards. Accountable for...Temporary workWork experience placementWork at officeWorldwide$230k - $250k
...Director, Global Regulatory Affairs - Strategy Lead Olema Oncology is a clinical-stage biopharmaceutical company committed to transforming the standard of care and improving outcomes for patients living with breast cancer and beyond. With our transformation into a...Work at officeFlexible hours2 days per week- ...Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy is responsible for developing and implementing global strategies to secure and maintain...Temporary workWorldwide
- Akebia Therapeutics in Cambridge, MA is seeking a Director of Regulatory Affairs - Labeling. This high-visibility role shapes global labeling strategy and partners cross-functionally to ensure labeling complies with FDA and global requirements. You will influence senior...Work at officeRelocation
$171.6k - $286k
...member of myGwork - the largest global platform for the LGBTQ+ business... ...We are seeking an experienced regulatory leader to join our Global Regulatory Strategy organisation, supporting the Respiratory... ...and Inflammation portfolio. As Director, Global Regulatory Strategy, you...Work at officeLocal areaRemote work$186.23k - $279.35k
...you will:Provide strategic and operational regulatory leadership to the development, commercialization... ...teams. Apply knowledge of current local and global Regulatory trends to identifyfuture regulatory requirements and strategies. Influence Regulatory authorities through...Full timeTemporary workWork at officeLocal areaWorldwideFlexible hours3 days per week- Moderna Associate Director, Global Regulatory-CMC will lead regulatory strategies for biologics or small molecules across lifecycle stages. You will shape global CMC plans, align with development teams, and drive submissions. The role requires 5+ years in biologics CMC,...
- Planet Pharma is seeking a senior regulatory leader to define and execute global labeling strategy across the product lifecycle. You will translate clinical evidence into scientifically substantiated labeling proposals and negotiate with global regulators, including the...
$153.6k - $241.34k
...A leading pharmaceutical company is seeking an Associate Director, Global Regulatory Affairs for GI & Inflammation programs in Boston, MA. This role involves leading regulatory strategies, maintaining compliance, and coordinating with health authorities. The ideal candidate...- ...company in Cambridge, MA, seeks an experienced Associate Director of Regulatory Strategy to lead oncology therapeutic programs. This role requires... ...particularly in oncology, to ensure alignment between US and global strategies. Exceptional communication skills and...
- Ipsen seeks a Director, Global Consumer Strategy & Market Development, Migraine, to define and lead the global patient strategy for Dysport in migraine, spanning chronic and episodic forms. You will translate patient insights into market development, activation and patient...
- Overview Moderna Therapeutics is seeking an Associate Director of Regulatory Strategy to support programs within the oncology franchise in one of... ...vaccines based on messenger RNA technology in the US and other global markets. Responsibilities Serve as the global...
- ...R&D Position Summary We are seeking an experienced regulatory leader to join our Global Regulatory Strategy organisation, supporting the Respiratory, Immunology and Inflammation portfolio. As Director, Global Regulatory Strategy, you will provide strategic regulatory...Local area
- Xenon Pharmaceuticals Inc. is seeking a senior regulatory affairs CMC leader to supervise regulatory activities for major development and commercial assets. This role requires driving global CMC submissions, coordinating with cross-functional teams across regulatory, quality...
- ...Takeda Pharmaceutical Co. seeks a Director of PV Clinical Operations to oversee outsourced pharmacovigilance activities across trials, ensuring global harmonization, safety data integrity, and regulatory compliance. You will lead risk-based quality reviews, vendor oversight...
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