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REGULATORY AFFAIRS MANAGER (CMC SITE)

Facilitate product development, global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.. Provi...

CompanyBiospace
AddressNew Albany, OH
CategoryInformation Technology
Job typeFull time
Date Posted 6 hours ago See detail

Regulatory Affairs Manager (CMC Site) New

Biospace

New Albany, OH

Facilitate product development, global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.. Provi...

6 hours ago seen See more...

Regulatory Affairs Manager - Now Hiring

Abbott Laboratories

Texas, United States

$95000 - $190000 per year

Develops sound global regulatory strategies for new and modified medical devices. Prepares robust regulatory applications to achieve departmental and organizational objectives. Creates, reviews and approves engineering changes. Pr...

7 days ago seen See more...

Associate Manager, Regulatory Affairs (Hybrid) New

Iff Family Of Companies

Hazlet, NJ

Working with a team of regulatory Specialists and Managers. This will require the ability to work in a team environment and contribute to collaborative projects. Providing support for all product compliance/regulatory, product cla...

19 hours ago seen See more...

Manager, Global Regulatory Affairs CMC New

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...

23 hours ago seen See more...

Manager, Regulatory Affairs- North America (Hybrid)

Iff Family Of Companies

Hazlet, NJ

Mentoring and working with a team of regulatory Specialists and Managers. This will require the ability to work in a team environment and contribute to collaborative projects. Providing support for all product compliance/regulator...

yesterday seen See more...

Manager, CMC Regulatory Affairs - Remote OR West Chester, PA

Teva Pharmaceuticals

West Chester, PA

Provide CMC regulatory guidance to teams engaged in the development of new products by assessing and interpreting FDA/ICH/EMEA regulatory guidance and directives, and evaluating and communicating their applicability to the develop...

3 days ago seen See more...

Regulatory Affairs Manager Regional Regulatory Lead

Biospace

Washington, DC

Implement the US regulatory plan and obtain and maintain Clinical Trial Authorizations and Marketing Application approvals in the US. Provide content for and coordinate US regulatory documents and meetings in accordance with GRT s...

4 weeks ago seen See more...

Regulatory Affairs Manager

Freudenberg Group

Remote

$94.6K - $120K a year

Provide regulatory excellence to the organization and guide decision making Responsible to direct, coordinate and supervise activities of Regulatory Affairs staff. Establish project priorities, ensure resources are available and b...

4 weeks ago seen See more...

Regulatory Affairs Manager - Core CRM Sustaining Program Regulatory POC

Boston Scientific

Saint Paul, MN

Oversite management of Core CRMRegulatory AffairsSustaining Program activities, with an emphasis on Leads and Lead accessories product portfolio. Manage a 3-4 person submissions team within a matrixed organization. Lead the CRM...

4 weeks ago seen See more...

Manager, Regulatory Affairs CMC - Now Hiring

Takeda Pharmaceutical

New York, NY

The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, c...

4 days ago seen See more...

Export Compliance and Regulatory Affairs Manager

Lightpath Technologies

Orlando, FL

$84.7K - $107K a year

Paid vacation with option to rollover vacation hours and sell hours back to company for payout at full rate. Paid sick time. 10 paid company holidays Employee Stock Purchase Program Employer Paid Life Insurance, Personal Accident...

a month ago seen See more...

Regulatory Affairs Manager - Electrophysiology

Abbott Laboratories

Minnesota, 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...

a month ago seen See more...

Regulatory Affairs Manager

Pramand Llc

Bedford, MA

$97.2K - $123K a year

Regulatory Strategy Formulate and execute regulatory strategies to assure timely and successful product approvals. Provide regulatory guidance to crossfunctional teams to support product development and commercialization. Regula...

a month ago seen See more...

Regulatory Affairs Manager

Sonablate Corp.

Indianapolis, IN

$110,000 - $120,000 a year

Develop and implement regulatory strategies to support domestic and global expansion efforts. Stay current on new and emerging compliance procedures and regulatory enforcement trends/actions. Track regulatory updates with emerging...

a month ago seen See more...

Regulatory Affairs Manager – Regional Regulatory Lead

Amgen

Washington, DC

$104,616 - $134,871 a year

Implement the US regulatory plan and obtain and maintain Clinical Trial Authorizations and Marketing Application approvals in the US Provide content for and coordinate US regulatory documents and meetings in accordance with GRT st...

a month ago seen See more...

Regulatory Affairs Manager

Siga Technologies, Inc.

Corvallis, OR

$115,000 - $125,000 a year

401(k). Dental insurance. Employee assistance program. Employee discount. Flexible spending account. Health insurance. Health savings account. Life insurance. Paid time off. Parental leave. Professional development assistance. Ref...

a month ago seen See more...

Regulatory Affairs Manager II

Bio-Rad Laboratories, Inc.

Irvine, CA

$149,000 - $204,800 a year

Advise site-based teams of appropriate actions in response to identified product compliance requirements. Lead QSD Regulatory Affairs team to meet business needs for product premarket approvals, clearances, and registrations neede...

a month ago seen See more...

Regulatory Affairs Manager

Blueroot Health

United States

$111K - $140K a year

Oversight for coordination and execution of regulatory requirements (as defined under DSHE, NLEA, Medical Foods and Medical Devices) and procedures, ensuring full compliance across all brands of the Company. Management coordinatio...

a month ago seen See more...

Regulatory Affairs Manager

Immune Deficiency Foundation

Washington, DC

$65,000 - $75,000 a year

Juris Doctorate or Masters degree in Public Policy, Public Administration, Political Science or related field desirable or equivalent Experience. Experience working within a governmental agency focused on health or for a patient...

a month ago seen See more...

Regulatory Affairs Manager

Aesku Inc.

Des Plaines, IL

$93.6K - $118K a year

Design studies with input from marketing and R&D, and (as needed) regulatory consultants, minimizing samples and tests required. Coordinate with sample vendors and internal trial sites to procure, store, and manage trial samples i...

a month ago seen See more...

Regulatory Affairs Manager (Medical Device/Cosmetic) - Long Beach, California (Hybrid)

Beautyhealth

Long Beach, CA

$130,000 - $150,000 a year

Lead all Regulatory Affairs projects to ensure compliance with all international, federal, state, and local facility/product registration, licensing, and reporting requirements for cosmetics and medical devices. Support in managin...

a month ago seen See more...

Regulatory Affairs Manager - Biologics

Huvepharma, Inc.

Lincoln, NE

$113,000 - $135,000 a year

Bachelors degree required, Masters Degree preferred, in Biology, Microbiology, or similar life sciences. 10-14 years relevant regulatory experience in either the veterinary biopharmaceutical or biologicals industry. More than 5...

a month ago seen See more...

Sr. Regulatory Affairs Manager

Mass General Brigham Health Plan

Somerville, MA

$129K - $163K a year

Lead the management of a portfolio of federal regulations, inclusive of policy development, external advocacy work, and gathering internal feedback in support of the advocacy work. Serve as the regulatory subject matter expert on...

a month ago seen See more...

Regulatory Affairs Manager

Skylls Solutions

Colchester, IL

$71,562.33 - $90,000.00 a year

401(k). Dental insurance. Health insurance. Paid time off. Vision insurance. Monday to Friday. Candidate Email:-. Regulatory Affairs Manager: 4 years (Required). financial accounting: 4 years (Required). Colchester, IL 62326: Relo...

a month ago seen See more...

Companion Diagnostic Regulatory Affairs Manager

Biospace

Washington, DC

Providing critical strategic and tactical IVD/CDx regulatory guidance that positively influences project planning & decision making. Developing clinical and commercial regulatory strategies for assigned products to enable successf...

a month ago seen See more...

Regulatory Affairs Manager

Inspira Financial

Oak Brook, IL

$106K - $134K a year

Actively engage with the Compliance leadership to develop, implement, and maintain Companys compliance program, including policies, procedures, system monitoring, technology, training, and communications. Assist in validating imp...

a month ago seen See more...

Regulatory Affairs Manager

Immune Deficiency Foundation Inc.

Hanover, MD

$65,000 - $75,000 a year

Monitor, analyze, and draft responses to a prescribed set of regulatory and reimbursement-related issues and represent IDF before state and federal agencies. Engage with the agencies, including but not limited to centers within th...

2 months ago seen See more...

Marine Regulatory Affairs Manager

Yamaha

Cypress, CA

Interact directly with regulators and lawmakers when appropriate and with the guidance of Yamahas management and when possible, in coordination with NMMA. Develop strong relationships with the National Marine Manufacturers Associ...

2 months ago seen See more...

CMC Regulatory Affairs Manager

Katalyst

Tarrytown, NY

Lead the preparation, review, and submission of CMC sections of regulatory filings (e.g., INDs, NDAs, BLAs, MAAs, variations, renewals) to global health authorities, ensuring accuracy, completeness, and compliance with applicable...

2 months ago seen See more...

Regulatory Affairs Manager

Aditi Consulting

Thousand Oaks, CA

Assist Regional Regulatory Representative to support regional regulatory activities (e.g. IMPD development and submission, advisory committee meeting preparations). Create and maintain product regulatory history documents through...

2 months ago seen See more...

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