Home
>
Jobs in ahmedabad
>
Amneal Pharmaceuticals
>
Manager, Regulatory Affairs

Manager, Regulatory Affairs

Amneal Pharmaceuticals

11 - 16 years

16 - 18 Lacs

ahmedabad

Posted:5 hours ago| Platform:

Apply

Skills Required

injectables fda pharmaceutical usfda biologics regulatory anda nda ich ra change control ctd clinical research quality assurance sterile biosimilars regulatory affairs cmc drug regulatory affairs dmf regulatory guidelines us market who

Work Mode

Work from Office

Job Type

Full Time

Job Description

IND/NDA/ANDAs/Amendments and Biologics to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws
The Manager, Regulatory Affairs CMC is responsible for developing and implementing regulatory strategies related to Chemistry, Manufacturing, and Controls (CMC) for pharmaceutical or biologic products
Having prior experience of handling pre-approval and post-approval regulatory activities for multiple dosage form including Sterile, Sterile (Injectables/Ophthalmic/Otic/IV Bags) dosage forms in US market either for Aseptic sterilization or Terminal sterilization or both

More Jobs at Amneal Pharmaceuticals

Manager, Packaging

Ahmedabad, Gujarat, India

Experience: Not specified

Salary: Not disclosed

Associate

Ahmedabad, Gujarat, India

Experience: Not specified

Salary: Not disclosed

Executive, EH&S

Ahmedabad, Gujarat

Experience: Not specified

Salary: Not disclosed

Trainee Executive

Ahmedabad, Gujarat

Experience: Not specified

Salary: Not disclosed

Trainee Executive

Ahmedabad, Gujarat

Experience: Not specified

Salary: Not disclosed

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.