Cmc Manager jobs

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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 7 days ago See detail

Regulatory Affairs Manager (CMC Site)

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...

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...

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...

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...

Manager, Global Regulatory Affairs CMC Submissions Management

Takeda Pharmaceutical

Bronx, NY

$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...

Manager Global CMC Regulatory Affairs

Johnson & Johnson

Titusville, NJ

Develops and realize global regulatory strategies for development compounds and marketed products according to scientific and risk-based principles. Participates as regulatory lead on CMC/VCM teams and represents CMC RA by provid...

Manager, Regulatory Affairs CMC

Pix11

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...

Manager, Regulatory Affairs CMC - Now Hiring

Takeda Pharmaceutical

Bronx, 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...

Manager, 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...

Associate/Manager – CMC Regulatory

Biospace

Sylvania, PA

Responsible for the generation and execution of country specific CMC regulatory strategies. Author and review global CMC dossiers. Coordinate and contribute to responses to regulatory agency questions. Participate as an active mem...

Associate Director - CMC Program Management

Biospace

Indianapolis, IN

Drive development of CMC operations in collaboration with CMC and program teams. Work with CMC and program team members to operationalize CMC strategy and integrate into the cross-functional program schedule. Manage multiple devic...

Manager, Regulatory Affairs CMC - Now Hiring

Takeda Pharmaceutical

Brooklyn, 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...

Manager, CMC Regulatory Affairs - West Chester, PA

Teva Pharmaceuticals

West Chester,

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...

Utilization Review Case Manager CMC

Utmb Health

Friendswood, TX

Demonstrates thorough knowledge of Inter Qual Criteria, CMC Specialty Referral Guidelines and Protocols used to determine status for inpatient admission or observation in Community Hospitals and UTMB-TDCJ Hospital. Performs utiliz...

CMC 2 Manager- Regulatory Affairs

Raise In Partnership With Genpact

United States

$103K - $131K a year

Well versed in performing CMC compliance activities including Gap Analysis, CMC comparison and validation for the quality reports Experienced in authoring of assessment reports and Part2/ Expert reports for Dossiers Experience in...

Senior Manager, Regulatory Affairs, CMC

Beigene

Remote

$133,400 - $178,400 a year

Lead, develop and implement small molecule CMC regulatory strategies as well as authoring CTD CMC sections for the assigned project to ensure on-time and high- quality global submissions for investigational, market, and post-appro...

Sr. Manager, Regulatory Affairs CMC (Remote)

Ptc Therapeutics

Remote

Leads and manages the development of Module 2 and 3 CMC documents for regulatory filings such as INDs/IMPDs/CTAs and MAAs/NDAs/ global registrations and eCTD submissions, ensuring that they meet current regulatory standards and ar...

Manager, Regulatory Affairs CMC

Takeda Pharmaceutical

Boston, MA

$133,000 - $209,000 a year

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...

CMC Program Development Manager

Biospace

Boulder, CO

Project Management. Lead programs, or series of related projects spanning multiple years, with specific oversight of quality, delivery, & cost.Coordinate contract resources & internal resources. Partner with cross-functional teams...

Sub-Section Manager - Commercial CMC Analysis

General Electric

Ohio, United States

Provide leadership and technical direction for assigned program tasks and personnel. Provide support council and recommendations to section management. Establish work group goals within framework of section technical and financial...

Scientific Marketing Manager - CMC

Pharmaron

Remote

$93.4K - $118K a year

Lead the development and execution of comprehensive, multi-channel marketing campaigns. Collaborate with scientific leaders to create compelling content for Scientific Marketing collateral. Translate complex scientific concepts in...