Global Regulatory Strategy Director, Immunology
BioSpace
Beeline Medicines in Boston is seeking a Director, Regulatory Strategy – Global Regulatory Lead to shape integrated global regulatory plans for early-stage immunology and inflammation programs, including lupus. You will guide development teams and coordinate across FDA, EMA, and other major authorities to ensure regulatory soundness from pre-IND through Phase II. You will collaborate with Clinical Development, CMC, Non‑Clinical Sciences, and Bioanalytics to drive IND/CTA and NDA/BLA submissions, #J-18808-Ljbffr BioSpace
Vacancy posted 6 hours ago
Similar jobs that could be interesting for youBased on the Global Regulatory Strategy Director, Immunology in Boston, MA vacancy
- Monte Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This strategic role... ...developing and executing regulatory strategies to support global product development, particularly in immunology. The successful candidate will have at least...Suggested
- Takeda is looking for a Director, Global Regulatory Lead Oncology in Boston, MA. This role encompasses setting the global regulatory strategy and overseeing all regulatory activities for high-impact oncology programs. You will collaborate with cross-functional teams to...Suggested
- Moderna, Inc. is seeking a Director of Regulatory Strategy to lead regulatory plans for select programs in rare, autoimmune, and oncology portfolios. This role requires strategic leadership within Global Regulatory Science to address challenges in gaining market approval...Suggested
- Discover International is seeking an Associate Director or Director to lead Global Regulatory Affairs on an initial contract. You will drive regulatory strategy, lead FDA interactions and manage submissions for multiple development programs, with potential conversion to...SuggestedRemote jobPermanent employmentContract work
- Moderna, Inc. is seeking a Director of Regulatory Strategy to lead global regulatory plans for assigned programs in rare, autoimmune and oncology portfolios. You will shape strategy, communicate risks and opportunities, and negotiate with health authorities in the US and...Suggested
$200k - $300k
A biopharmaceutical company in Cambridge is seeking a Director or Senior Director of Regulatory Strategy. This role involves developing and implementing global regulatory strategies for clinical programs and leading interactions with regulatory authorities. Candidates should...- ...lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products... ...LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL II) Global Regulatory Strategy is responsible for developing and...Temporary workWorldwide
- ...United States is seeking an experienced Associate Director / Director of Regulatory Affairs to lead global regulatory activities and ensure compliance with applicable... .... This hands-on role will influence regulatory strategy, prepare and manage submissions, and navigate...
Treeline
Watertown, MA20 hours ago - A leading pharmaceutical company is looking for a Director of Regulatory Affairs to provide strategic and operational leadership in developing... ...communication and leadership skills. This role is vital for supporting ongoing global clinical studies. #J-18808-Ljbffr Noema Pharma AG
$196.7k - $353.4k
The RoleModerna is seeking an individual to lead development and execution of global regulatory strategy for programs in its oncology portfolio. This leader will shape regulatory pathways for novel, first-in-class therapeutics and drive successful global development and...Permanent employmentFull timeWork at officeWork from home$186.23k - $279.35k
...about science and experienced within regulatory affairs and drug development? Do you... ...affairs to get involved in the global regulatory strategies and support the research, development... ...the business. The Regulatory Affairs Director (RAD) provides strategic and operational...Hourly payFull timeTemporary workWorldwide3 days per week- ...to provide strategic direction across global immunology programs. You will guide clinical development... ...product profiles, and indication strategies, ensuring scientific rigor and patient... ...leading cross-functional teams, regulatory interactions, and governance communications...
- ...Sanofi is seeking a Finance Director - Global Immunology to lead franchise financial planning, reporting, and strategic investments across regions. You will partner with commercial, R&D and leadership to optimize performance and allocate resources for this therapeutic...
BioSpace
Cambridge, MA20 hours ago $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- Akebia Therapeutics seeks a Director, Regulatory Affairs - Labeling to shape global labeling strategy across our portfolio. You will serve as the enterprise expert on labeling, partnering with Clinical, Medical Affairs, Commercial, Legal, Safety, and CMC to ensure robust...
- Vertex Pharmaceuticals Incorporated seeks a Director of Chemistry Manufacturing Controls (CMC) to lead a Regulatory CMC team responsible for global regulatory strategies across a small molecule portfolio. You will guide content for submissions, engage Health Authorities...
$167k - $300.7k
The Role Moderna, Inc. is seeking a Director of Regulatory Strategy to support select programs within the rare, autoimmune and oncology portfolios... ...markets. The Director will be a strategic leader within Global Regulatory Science, responsible for developing and executing...Permanent employmentWork at officeWork from home- Relay Therapeutics in Cambridge, MA is seeking a motivated regulatory professional to join their dynamic team. You will support innovative regulatory strategies and manage global submissions including IND, CTA, NDA, and MAA. The ideal candidate has a B.S./M.S. with 2+ years...
$189k - $246k
Travere Therapeutics, located in Boston, is seeking a Director of Regulatory Affairs Strategy. The role involves developing and executing global regulatory strategies for Phase 2 and Phase 3 drug development programs. As the regulatory lead, you will ensure compliance,...Remote job$150k - $195k
...target key pathways governing dysregulated immunological and inflammatory responses, the... ...fully. Job Summary: The Senior Manager, Regulatory Strategy supports the development and execution... ...candidate brings working knowledge of FDA and global regulatory frameworks, sound...Local areaFlexible hours2 days per week- ...experienced labeling professional to join our labeling strategy team. This team is responsible for developing... ...or Philadelphia, PA Key Responsibilities Represent Global Labeling on product-specific Global Regulatory Teams and other cross-functional product, development...Local area
$210k - $235k
...clinical development, commercial strategy, and beyond. Innovation: Work on... ...across functions and geographies. The Director, Regulatory Strategy provides global regulatory leadership and... ...one or more development programs in immunology. This role is accountable for shaping...Remote workWorldwideFlexible hours$168k - $252k
Job DescriptionGeneral 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...Full timeSummer workRemote workFlexible hours2 days per week$270k - $380k
...create an unparalleled, direct impact.The OpportunityLeads 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 officeWorldwideGalderma
Boston, MA20 hours ago$211.5k - $258.5k
...that directly target key pathways governing dysregulated immunological and inflammatory responses, the Company is developing... ...diseases can live life fully. Job Summary The Director, Regulatory Strategy - Global Regulatory Lead is responsible for developing and leading...Local areaFlexible hours2 days per week- State Street is seeking the Global Head of Regulatory Examination Management within the Global Regulatory Liaison Office to lead the firm’s global examination program, coordinating intake, scope, scheduling, responses, and closeout across jurisdictions. The role requires...Work at office
- Genesys is seeking a Senior Director, Global Partner Strategy & Programs to define and execute our global partner strategy and programs, enabling partner-led growth across regions. The role collaborates with regional sales leaders and executive stakeholders to align priorities...Remote job
- 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...
- Vertex is seeking an Alliance Management Executive Director to lead the Alliance Management team and support the execution of global partnerships. You will ensure a consistent user experience, manage governance, drive issue resolution, and engage senior stakeholders across...
- ...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...
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Global Regulatory Strategy Director, Immunology. Be the first to apply!
Related searches
- regulatory affairs manager pharmaceutical Boston, MA
- compliance director Boston, MA
- regulatory affairs director Boston, MA
- regulatory affairs manager medical devices Boston, MA
- associate director compliance Boston, MA
- corporate compliance manager Boston, MA
- manager regulatory affairs Boston, MA
- regulatory manager Boston, MA
- sr. manager regulatory compliance Boston, MA
- senior regulatory manager Boston, MA