Manager, Clinical Regulatory Affairs

Amneal Pharmaceuticals

11 - 16 years

35 - 40 Lacs

ahmedabad

Posted:12 hours ago| Platform:

Apply

Skills Required

technical operations document review clinical development research strategy development regulatory affairs

Work Mode

Work from Office

Job Type

Full Time

Job Description

:

Develops and implements submission strategies for 505(b)(2), ANDAs and NDAs.
Leads and ensures implementation of the planning, writing and review of all regulatory submissions to support of all global projects for ANDAs and 505(b0(2) NDAs and EU and UK Marketing Authorizations.
Critically reviews and approves documentation from clinical development, non-clinical development, Research and Development (R&D), Quality, Technical Operations, Labeling and other appropriate departments, internal and stakeholders, vendors and consultants.
Ensures that project timelines are developed and communicated; evaluates changes to maintain submission goals and timelines; communicates any delays along with the rationale.
Interprets regulations and guidance documents and provides strong regulatory leadership to project teams to ensure regulatory success.
To supports Specialty projects and International Markets.
To develop strategies during product development, authoring submissions and providing required responses to Regulatory Agencies.

Required Skills:

Global Regulatory Submissions | Advance
Regulatory Strategy Development | Expert
Documentation Review & Approval | Advance
Product Development Support | Advance
International Regulatory Knowledge | Intermediate

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.