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Full-Time Regulatory Manager jobs

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SR. MANAGER, REGULATORY STRATEGY

Develops and contributes to content, format and accountability for regulatory submissions and related supplements and amendments, including FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plan...

CompanyBiospace
AddressCambridge, MA
CategoryInformation Technology
Job typeFull time
Date Posted just now See detail

Sr. Manager, Regulatory Strategy New

Biospace

Cambridge, MA

Develops and contributes to content, format and accountability for regulatory submissions and related supplements and amendments, including FDA meeting requests, briefing books, INDs, CTAs, orphan drug designations, pediatric plan...

just now seen See more...

Manager, Global Regulatory Affairs, Marketed Products New

Biospace

Boston, MA

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with TakedasPrivacy Noticeand Terms of U...

11 minutes ago seen See more...

Senior Manager, Regulatory Affairs Project Management and Strategic Planning

Biospace

Remote

You will lead cross functional project submission working groups (SWG) to deliver successful submissions/filings and outcomes with Health Authorities (HA) for early to late phase development programs by providing effective Project...

yesterday seen

Senior Manager, Public Policy, International Government and Regulatory Affairs (IGRA)- Hybrid

Biospace

Rockville, MD

We are committed to creating an inclusive environment in all aspects of our workan environment where every employee feels fully empowered and valued irrespective of, but not limited to, race, ethnicity, physical and mental abiliti...

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Regulatory Writing Manager

Biospace

Los Angeles, CA

Write or lead all aspects of the writing of clinical study reports and Investigator Brochures for products in all phases of clinical development (phases 1-4). Write CTD sections including the Summary of Clinical Efficacy, Summary...

2 days ago seen See more...

Regulatory Writing Senior Manager

Biospace

Washington, DC

Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies,...

2 days ago seen See more...

Senior Manager, Global Regulatory Labeling Strategy

Biospace

Remote

Leads Labeling cross-functional teams, facilitates discussions on labeling strategies and content for assigned product(s) and ensures cross-functional collaboration and alignment, for assigned product(s), with appropriate supervis...

5 days ago seen

Manager, Global Regulatory Affairs CMC Submissions Management

Biospace

Lexington, 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 Submissions Management in...

6 days ago seen See more...

Senior Manager, Regulatory Affairs - General Medicine

Biospace

Basking Ridge, NJ

Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amend...

6 days ago seen See more...

Quality and Regulatory Systems Implementation -Manager-Consulting

York State Department Of Labor

New York, NY

Quality Management Systems (including complaint management, CAPAs, deviations, change control, quality audit management, supplier quality management, etc.). Regulatory Affairs (regulatory submissions, Health Registration Managemen...

a week ago seen See more...

Quality and Regulatory Systems Implementation -Manager-Consulting

York State Department Of Labor

New York, NY

Quality Management Systems (including complaint management, CAPAs, deviations, change control, quality audit management, supplier quality management, etc.). Regulatory Affairs (regulatory submissions, Health Registration Managemen...

a week ago seen See more...

Senior Manager CMC Regulatory Affairs

Biospace

Basking Ridge, NJ

Responsible for CMC/CP product development activities to lead the regulatory standpoint during early phase, development, submissions and post market requirements. Participate in IOPS cross-functional meetings for program-specific...

2 weeks ago seen See more...

Casino Regulatory Manager

Commonwealth Of Massachusetts

Plainville, MA

Assist the Gaming Agents Division Chief with the creation of policies and procedures within the Investigations and Enforcement Bureau (IEB), Gaming Agents Division, recommend regulations, policies and procedures in order to improv...

a month ago seen See more...

Regulatory Policy Manager - Credit Valuation Adjustment

Hsbc

New York, NY

Track new policy developments and formulate HSBCs regulatory capital policies accordingly, providing detailed, actionable guidance, distributed to a wide range of stakeholders. The US GRPA team is responsible for monitoring new d...

2 weeks ago seen See more...

Manager, Global Regulatory Affairs, Marketed Products - Now Hiring

Takeda Pharmaceutical

Bronx, NY

$186,000 per year

By clicking the Apply button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takedas and. I further attest that...

3 weeks ago seen See more...

Manager, Global Regulatory Affairs CMC - Now Hiring

Takeda Pharmaceutical

Brooklyn, NY

$133,200.00 to $223,200.00 per year

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...

3 weeks ago seen See more...

Financial Services - Regulatory Compliance - Manager 1 1

York State Department Of Labor

New York, NY

Consistently deliver quality client services. Monitor progress, manage risk and ensure key stakeholders are kept informed about progress and expected outcomes. Stay informed of current business and industry trends relevant to the...

3 weeks ago seen See more...

Financial Services - Regulatory Compliance - Manager 1

York State Department Of Labor

New York, NY

Leading your own engagement team; interacting and developing relationships with clients top executives and our firms leadership. Providing guidance and relevant expertise to help your team build strategic and innovative solution...

3 weeks ago seen See more...

Financial Services - Regulatory Compliance - Manager

Ernst & Young Llp

New York, NY

Competitive

Leading your own engagement team; interacting and developing relationships with clients top executives and our firms leadership. Providing guidance and relevant expertise to help your team build strategic and innovative solutio...

3 weeks ago seen See more...

Manager - Regulatory Affairs - Therapeutic Area

Biospace

Plainsboro, NJ

Compile and submit responses to FDA communications. MANAGER, THERAPEUTIC AREA: Compile, submit and maintain applications (IND, NDA, Biologics, Devices) to government agencies in support of research and marketed products. Create an...

4 weeks ago seen See more...

Manager, Global Regulatory Affairs CMC Submissions Management - Now Hiring

Takeda Pharmaceutical

New York, United States

$138,500 - $186,000 per year

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 Submissions Management in...

4 weeks ago seen See more...

System Manager Epic Quality and Regulatory Reporting

Commonspirit Health

Englewood, CO

$51.66 - $74.91 an hour

Bachelors Degree required, Masters Degree preferred. 10 years healthcare experience required. 5-7 years of leadership experience with direct reports required. Healthcare Clinical Licensure required Nursing, pharmacy, therapy. E...

4 weeks ago seen See more...

Senior Manager/Associate Director, Regulatory Affairs, Strategic Global Labeling - Combination

Biospace

North Chicago, IL

Develop and direct strategic regulatory planning, creation, and revision of labeling for combination product and device submissions (pre and post approval) with an understanding of Global requirements to lead the Labeling Sub team...

4 weeks 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...

4 weeks ago seen See more...

Regulatory Operations Submissions Manager - OneSource Regulatory

Onesource Regulatory

Chicago, IL

$105K - $133K a year

Regulatory Operations service provider to over 100 small to large sized companies Process Optimization. System Implementations. Document Management. Submission Management. Publishing. Archiving. RIM. Submission Managers. Publisher...

4 weeks ago seen See more...

Regulatory Operations Project Manager - OneSource Regulatory

Onesource Regulatory

Chicago, IL

$102K - $129K a year

Regulatory Operations service provider to over 100 small to large sized companies Process Optimization. System Implementations. Document Management. Submission Management. Publishing. Archiving. RIM. Submission Managers. Publisher...

4 weeks ago seen See more...

Quality & Regulatory Project Manager

Abbott Laboratories

Illinois, United States

$95,000 - $190,000 a year

Career development with an international company where you can grow the career you dream of. Free medical coverage for employees* via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer con...

4 weeks ago seen See more...

Regulatory Reporting Manager

Bank Of America

Charlotte, NC

$126K - $160K a year

Detailed analysis and review of data reported on the FR Y-14Q, FR Y-9C, and FFIEC 031 Ensure the robustness of key reporting and process controls, including submission trend and variance analysis Establish working relationships wi...

4 weeks ago seen See more...

Regulatory Risk & Oversight Manager

Northern Trust

Chicago, IL

Unspecified

Responsible for supporting the definition and leading the execution against the identified pillars of the Program as a named Program Lead. Over time identifying and managing a small global team who will enable execution of the new...

4 weeks ago seen See more...

System Management & Regulatory Specialist

Pseg

Newark, NJ

Ensure proper execution of technical controls associated with regulatory compliance programs including NERC CIP, SOX, BPU and FERC Affiliate Restrictions. Manage patching cycles for workstations and servers associated with Securit...

a month ago seen See more...

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What companies are hiring for Full-Time Regulatory Manager jobs?

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