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Head Of Regulatory jobs in Waltham, MA

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EXECUTIVE DIRECTOR, HEAD OF CLINICAL PHARMACOLOGY AND PHARMACOMETRICS

Work vertically and horizontally across Research and Development to ensure robust, innovative, and consistent Clinical Pharmacology and Pharmacometrics strategies across the pipeline from pre-IND through early and late development...

CompanyBiospace
AddressCambridge, MA
CategoryEducation/Training
Job typeFull time
Date Posted 5 hours ago See detail

Executive Director, Head of Clinical Pharmacology and Pharmacometrics New

Biospace

Cambridge, MA

Work vertically and horizontally across Research and Development to ensure robust, innovative, and consistent Clinical Pharmacology and Pharmacometrics strategies across the pipeline from pre-IND through early and late development...

5 hours ago seen See more...

Head of Quality Operations

Biospace

Bedford, MA

Partner across the organization to define and implement a clear quality vision and strategic plan from Phase I/II clinical to commercial to support companys goals for the development, manufacture, and future global commercializat...

2 days ago seen See more...

Senior Director, Regulatory Information Management

Biospace

Waltham, MA

Develop and implement the strategy for Regulatory Information Management including processes and optimization of systems. Develop and implement the strategy for operationalizing simultaneous marketing application filings in multip...

3 weeks ago seen See more...

Head of Development, Ex Vivo Programs

Biospace

Cambridge, MA

Accountable for the achievement of program milestones in scope, time, budget together with sub-team leads and functional leads that is aligned with corporate strategy. Ensures cross-functional plans are supporting the overall prog...

3 days ago seen See more...

Head of Global Communications Planning & Operations

Biospace

Cambridge, MA

Act as a thought partner to the head of Global Communications and leadership team on overall organization strategy and programs. Develop and implement strategic roadmap, in line with the organizations ambitious vision and mission...

6 days ago seen See more...

Vice President, Head of Compliance

Dyne Therapeutics

Waltham, MA

Responsible for establishment and leadership of an effective global healthcare compliance program. Strategic compliance advisor to the Board of Directors and the management team. Healthcare law and data privacy legal advisor to th...

4 weeks ago seen See more...

Head of Enterprise Data Quality and Marketplace

Biospace

Boston, MA

You will own the global and Enterprise Data Quality and Marketplace function and deliver the Enterprise Data Quality, Data Catalog, Data Security & Audits, Data Acquisitions & Marketplace Strategy globally. Chair / Co-Chair the En...

2 days ago seen See more...

Head of Digital Ethics & Compliance Global Portfolio Division

Biospace

Boston, MA

Ethical behaviour plays a fundamental role in risk mitigation.. Being a forward-thinking leader in risk identification and mitigation. Building a modern function supporting achievement of Takedas Vision. Act as role model for Tak...

2 days ago seen See more...

Senior Manager/Associate Director, Regulatory Strategy

Biospace

Boston, MA

Throughour in-depth understanding of the biological pathways involved inmineralization, we are pursuing the development of therapeutics to address theunderlying causes of these debilitating diseases. You will develop and implement...

2 days ago seen See more...

SVP, Global Regulatory Affairs

Biospace

Waltham, MA

Ensure the development, preparation, and implementation of global strategic regulatory plan for all programs and product pipeline designed to maximize successful and expedient global product registrations. Responsible for managing...

a month ago seen See more...

SVP, Head of Data Analytics

Biospace

Waltham, MA

Provide strategic direction and leadership for the Data Analytics function, aligning with corporate goals and objectives. Establish and execute on a strategic roadmap for biostatistics, statistical programming and data management...

a month ago seen See more...

VP, Head of Compliance

Biospace

Waltham, MA

Responsible for establishment and leadership of an effective global healthcare compliance program. Strategic compliance advisor to the Board of Directors and the management team. Healthcare law and data privacy legal advisor to th...

2 months ago seen See more...

Director, Regulatory Affairs

Biospace

Waltham, MA

Interact with other departments to develop regulatory strategy and submission plans for quality and timely filings. As a member of program teams, provide global regulatory guidance regarding requirements for clinical development a...

2 months ago seen See more...

Associate Director, Regulatory Operations

Biospace

Waltham, MA

Serve as an administrator for RIM and provide direct support to functional disciplines and program teams responsible for developing submission contents. Manage day-to-day submission activities both internally and in collaboration...

2 months ago seen See more...

Remote - Sr. Regulatory Affairs Associate - Pharmaceuticals

Fresenius Medical Care

Waltham, MA

Provides regulatory assessment and support. Evaluates and assesses regulatory impact of proposed product changes. Contributes to strategic planning as regulatory representative on interdepartmental pharmaceuticals development team...

2 months ago seen See more...

Remote - Regulatory Affairs Associate II Pharma

Fresenius Medical Care

Waltham, MA

$87.1K - $110K a year

Provides regulatory assessment and support. Evaluates and assesses regulatory impact of proposed product changes. Contributes to strategic planning as regulatory representative on interdepartmental pharmaceuticals development team...

2 months ago seen See more...

Head, Advanced Analytic Services (Director)

Biospace

Boston, MA

Lead and manage multiple teams responsible for advancedtechnology services globally. Drive the development and implementation of advancedtechnologiesacrossvarious domains. Providestrategicdirection and leadership as a senior tech...

4 days ago seen See more...

Associate Director, Global Regulatory Labeling

Biospace

Cambridge, MA

Develop and maintain current knowledge of labeling regulations and industry standards for labeling and communicate requirements to stakeholders as needed.. Direct the labeling control process for tracking, implementation, and regu...

4 weeks ago seen See more...

Head of Patient Services, The Americas, Rare Diseases

Chiesi

Boston, MA

United States, Massachusetts, Boston

About us AIR (products and services that promote respiration, from new-born to adult populations), RARE (treatment for patients with rare and ultra-Rare Diseases) and CARE (products and services that support special care and consu...

a week ago seen See more...

Head of Financial Crimes Models & Analytics

Fidelity

Boston, MA

Lead a multi-disciplinary Analytics, Data Science and Data Engineering team with responsibility for design, development, execution and maintenance of Financial Crimes transaction monitoring models in support of Fidelity's brokerag...

a week ago seen See more...

Head of Biolife Management and Teardown Support

Biospace

Boston, MA

Define the network strategy of projects deployment following Plasma OpU objectives. Define in collaboration with all the manufacturing sites the Factories of the Future Strategy, with the aim to achieve the capacity targets. Defin...

a week ago seen See more...

Manager, Global Regulatory Affairs CMC

Biospace

Boston, MA

I further attest that all information I submit in my employment application is true to the best of my knowledge.Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs CMC in Cambridge, MA with the...

2 weeks ago seen See more...

Bio Pharma Segment Leader - Head of Sales

Capgemini North America

Boston, MA

For eligible employees, we offer: Flexible work Healthcare including dental, vision, mental health, and well-being programs Financial well-being programs such as 401(k) and Employee Share Ownership Plan...

2 weeks ago seen See more...

Head of Engineering

Recruiting From Scratch

Cambridge, MA

$160,000 - $220,000 a year

Take ownershipReport directly to co-foundersOversee engineering teamUnblocking engineers and providing mentorship Report directly to co-founders Oversee engineering team Unblocking engineers and providing mentorship Set culture an...

a month ago seen See more...

Vice President, Global Partnering Strategy & Operations Head / Chief of Staff

Ipsen Pharma

Cambridge, MA

Strategize the deals management to ensure Ipsen will deliver its ambition and annual objectives in terms of asset, company acquisition and/or partnership. Develop and lead Ipsen's governance for due diligence assessment and acquis...

a month ago seen See more...

Head of Biochemistry and Biophysics

Moma Therapeutics

Cambridge, MA

$159K - $201K a year

Will be part of an experienced and resilient team that is collectively unstoppable, trusts one another, and selflessly collaborates. Will work with incredible humans who are committed to the discovery of transformative medicines f...

2 months ago seen See more...

Hematology Lab Head and Group Leader

Pfizer

Cambridge, MA

$149,200 - $248,600 a year

Contribute to the development of a red cell health strategy in IMRU by identifying and prioritizing novel targets or pathways to treat key unmet medical needs. Manage a group of 6 scientists to support discovery research projects...

2 months ago seen See more...

Head of Oligonucleotide Biology

Simcere Of America Inc

Cambridge, MA

$113K - $143K a year

Lead the identification and mechanistic profiling and optimization of lead oligonucleotide compounds to provide high-value programs in line with Simcere's portfolio strategy. Make strategic and quality decisions for the programs i...

2 months ago seen See more...

Head of Clinical Operations

Ensoma

Boston, MA

A Bachelors Degree with at least ten years of Clinical Operations experience in the biopharmaceutical industry A thorough understanding of Clinical trial processes, including clinical project management, site management, clinical...

2 weeks ago seen See more...

Director, Global Regulatory Lead (Oncology)

Biospace

Boston, MA

Interfaces with the LRST and AST to lead and support cross-functional company objectives.Leads the GRPT to development of creative global strategies in line with applicable regulations to achieve business objectives for developmen...

2 weeks ago seen See more...

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