Senior Manager, CMC Regulatory Affairs Job in New Jersey (NJ), Regulatory Affairs Career, Jobs in Amicus Therapeutics
Sign in
Create a candidate account
Create a candidate account
Create an employer account
Sign in to an existing account
Create a candidate account
Create an employer account
Sign in to an existing account
Forgot password
Forgot password
Sign in
Create a candidate account
Sign in
Create an employer account

Senior Manager, CMC Regulatory Affairs job in Cranbury

Sign in
Create a candidate account
Amicus Therapeutics jobs
New Jersey (NJ), Cranbury
Job Code:  502
Employer:  Amicus Therapeutics
Category:  Regulatory Affairs

Location
Country:  United States
State:  New Jersey (NJ)
City:  Cranbury
10/05/2018

Description


Senior Manager, CMC Regulatory Affairs

Position Summary
Senior manager, CMC Regulatory Affairs will support and manage the CMC regulatory activities associated the products of Amicus Therapeutics throughout the lifecycle with minimum supervision. He is responsible for the integration of the regulatory CMC strategy of all submissions.

Roles and Responsibilities
This position will:

- Prepare, author, review, coordinate and manage CMC regulatory submissions, including original IND/IMPD, IND/IMPD amendments, annual reports and agency meeting briefing documents in accordance with applicable regulations
- Manage all the regulatory submission documents and the associated supporting documents
- Develop and maintain submission timelines for CMC related issues
- Act as liaison between Regulatory Affairs and other functional areas
- Represent Regulatory Affairs in cross-functional team meetings
- Translate regulatory requirements into practical, workable submission plans
- Provide thoughtful & accurate comments during document review per regulatory guidelines
- Review and communicate current and emerging regulatory requirements
- This position will report to the Senior Director of CMC Regulatory Affairs

ref: (502)
Back to search results

Popular locations: New Jersey (NJ) (480) | Maryland (MD) (428) | Illinois (IL) (377) | Pennsylvania (PA) (245) | Texas (TX) (201) | California (CA) (156) | Massachusetts (MA) (137) | North Carolina (NC) (98) | Delaware (DE) (81) | Indiana (IN) (57)

Popular categories: Research and Development (595) | Sales (243) | Information Technology (185) | Operations (183) | Marketing (101) | Clinical Research (87) | Business Development (73) | Other (65) | Laboratory (63) | Finance (61)

Popular jobs: Director (493) | Manager (463) | Sales (313) | Associate Director (203) | Project Management (82) | Business Development (77) | Clinical Data Management (40) | Senior Specialist (40) | Bioinformatics Scientist (20) | Account Manager (14)