Director, Global Regulatory Labeling Strategy
Akebia-Therapeutics-
Akebia Therapeutics is seeking a Director of Regulatory Affairs – Labeling to lead the global labeling strategy across its portfolio. The position requires extensive experience in regulatory labeling and the ability to influence cross-functional teams while ensuring compliance with FDA regulations. The role involves significant collaboration with clinical, medical, and commercial teams to optimize product value and streamline labeling processes. A Bachelor’s degree in a related field and at least 10 years of experience in the pharmaceutical or biotech sector are essential for this role. #J-18808-Ljbffr Akebia-Therapeutics-
- ...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...SuggestedLocal areaImmediate startWorldwide
$211.85k - $317.78k
...patients' lives. This is what you will do: The Senior Regulatory Affairs Director (Sr RAD), Global Regulatory Strategy, leads the development and implementation of... ...an efficient path to approval and competitive labeling, aligned with product attributes and the needs of...SuggestedHourly payTemporary workWork at officeFlexible hours3 days per week- ...Therapeutics is seeking an experienced and strategic Director of Regulatory Affairs to lead and support global regulatory efforts across our development programs... ...for developing and executing regulatory strategies that support global product development and registration...Suggested
- Takeda seeks an Associate Director, Global Labeling Lead to manage the development of labeling content for various products. This role demands... ...project management skills and extensive knowledge of US and EU regulatory requirements. Candidates should have over 8 years in the...SuggestedFull timeRemote work
$196.7k - $353.4k
Senior Director, Global Regulatory Strategy, Oncology page is loaded## Senior Director, Global Regulatory Strategy, Oncologylocations: Cambridge, Massachusetts: Clinical Developmenttime type: Full timeposted on: Posted Todayjob requisition id: R19032**The role**Moderna...SuggestedWork at officeWork from home$211.85k - $317.78k
Job Title: Senior Director, Global Regulatory Strategy - Early Development & Business Development Location: Boston, MA At AstraZeneca, we pride ourselves on crafting a collaborative culture that champions knowledge-sharing, ambitious thinking and innovation - ultimately...Hourly payTemporary workWork at office3 days per week- A leading BioPharmaceutical company seeks a Senior Director, Global Regulatory Strategy, to lead regulatory efforts for early-stage products and ensure alignment with health authority expectations. The role demands extensive regulatory experience in the pharmaceutical...
$200k - $260k
A leading consulting firm in health strategy seeks a Senior Director of Regulatory Strategy Consulting in Boston. In this role, you will utilize your substantial regulatory experience to shape global strategies and lead cross-functional teams. The ideal candidate possesses...Flexible hours$209.35k - $258.6k
Akebia Therapeutics(R), Inc. in Cambridge, MA is seeking a Director of Regulatory Affairs - Labeling. This leadership role will shape global labeling strategies for the product portfolio. Candidates should have over 10 years in regulatory labeling within pharmaceuticals...$154.4k - $242.55k
...Purpose: Defines, develops and leads global strategies to maximize global regulatory success towards achievement of... ...counterparts.Accountabilities:The Associate Director will be responsible for complex or... ...sub-working groups, such as the Label Working Group, and represents GRTs...Minimum wageTemporary workLocal areaImmediate startRemote work$177k - $278.08k
...worldwide. This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing... ...Independently develops the regulatory CMC strategy and leads the execution of regulatory... ...Growth & Emerging Markets, Strategy, Labelling, etc.) to ensure effective strategies...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$154.4k - $242.55k
...to patients worldwide. As an Associate Director, Global Regulatory Affairs Marketed Products you will: Lead/Contribute global strategies to maximize global regulatory success towards... ...sub-working groups, such as the Label Working Group, and represents GRT at project...Minimum wageTemporary workLocal areaRemote workWorldwide$238k - $374k
...to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Devices and Drug‑Device Combination... ...innovative and robust regulatory strategies for medical devices and drug‑device... ...nonconformances, clinical evidence, labeling/UDI, post‑market signals)....Minimum wageFull timeTemporary workWork at officeLocal areaRemote workWorldwide$177k - $278.08k
...patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing... ...develops the regulatory CMC strategy and leads the execution of regulatory... ...Growth & Emerging Markets, Strategy, Labelling, etc.) to ensure effective strategies...Minimum wageTemporary workLocal areaImmediate startRemote workWorldwide- Initial Therapeutics, Inc. is seeking a seasoned regulatory leader to develop and execute global regulatory strategy for its oncology portfolio. The role requires extensive experience in regulatory strategy with a focus on oncology, strong stakeholder engagement, and a...
$211.85k - $317.78k
AstraZeneca GmbH in Boston is seeking a Senior Regulatory Affairs Director to lead the global regulatory strategy for rare disease programs. The successful candidate will have an advanced degree and 10+ years of relevant experience, guiding cross-functional teams and managing...$246.33k - $304.29k
Akebia Therapeutics is seeking a Senior Director, Regulatory Affairs in Cambridge, MA to lead regulatory strategy and submissions for innovative therapies addressing chronic kidney disease. This role demands extensive regulatory experience, with leadership responsibilities...Flexible hours$115 - $125 per hour
Job Description The Regulatory Strategy Director will be responsible for the development and implementation of innovative global/regional regulatory strategies for assigned projects within... .... Experience with market product, labeling, new drug development and working with...Contract workLocal area$200k - $300k
...diseases that have high unmet need. As a global leader in the biology of the... .... Summary of Position The Director or Senior Director, Regulatory Strategy, reporting to the SVP, Global Head... ...SOPs, business development, clinical labeling, disclosure) as needed Candidate...Work at officeLocal areaShift work- ...leading oncology biotech company in Boston seeks an Executive Director of Global Regulatory Affairs. This crucial role involves providing strategic... ..., ensuring compliance, and overseeing global regulatory strategies. The ideal candidate will have over 15 years of...
- Monte Rosa Therapeutics, Inc is seeking a Director of Regulatory Affairs based in Boston. This strategic role involves developing and executing regulatory strategies to support global product development, particularly in immunology. The successful candidate will have at...
$209.35k - $258.6k
...life-changing work, and we are all in, are you? Job Summary The Director, Regulatory Affairs - Labeling is a highly visible leadership role responsible for shaping and executing global labeling strategy across Akebia’s portfolio. This individual will serve as the enterprise...Work at officeLocal areaRelocationFlexible hours- ...LinkedIn and Tik Tok. Job Description The Director Regulatory Affairs Global Regulatory Lead (GRL I) in Global Regulatory Strategy is responsible for developing and... ...include Area Lead (US/Canada) role. May lead the Labeling Regulatory Strategy Team (LRST). Ensures...Temporary workLocal areaWorldwide
- Allergan is seeking a Senior Director Regulatory Affairs Therapeutic Area Head in Cambridge, MA. This leadership role involves managing global regulatory strategies and supervising a team of global regulatory leads. Applicants should have over 10 years of experience in...
- ...seeking a product management leader to oversee its international product line. This role involves managing the strategy, vision, and execution of global white-label product offerings. The ideal candidate will have extensive experience in product management, strong...
$238k - $374k
...changing therapies to patients worldwide. As Executive Director, Global Regulatory Affairs CMC Early Development you will provide strategic... ...experts to ensure innovative, robust, fit-for-phase regulatory strategies for small molecule and biologic products for FIH to pre-...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide$270k - $330k
Title:Senior Director, Global Regulatory Affairs, Oncology Company:Ipsen Biopharmaceuticals Inc. About... ...and flawless execution of regulatory strategies for assigned products and projects, including... .... Assess impact on timelines and/or label; propose remediation where possible....Full timeTemporary workLocal areaWorldwideFlexible hours- ...A leading global biopharmaceutical company is seeking an Associate Director, Global Labeling Lead to manage labeling strategies for multiple products. The role requires 8+ years of industry... ...possess a strong understanding of regulatory requirements in the US and EU. This...Remote work
$153.6k - $241.34k
...worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be responsible... ...implementation of labeling content and strategy of multiple assigned products in... ...labeling content and processes conform to regulatory requirements. Management of Local...Minimum wageFull timeTemporary workLocal areaRemote workWorldwide- ...innovative therapies. About the Role : The Manager/Senior Manager, Regulatory Affairs — Advertising, Promotion & Labeling is responsible for supporting U.S. promotional regulatory strategy and related global initiatives. Responsibilities : Serve as the Regulatory...
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