Job Description

Associate – CSCC & RM (Regulatory Operations)

Job highlights
Experience in Regulatory Affairs with skills in module 1 coordination and submissions

Direct product registration submissions, interact with regulatory agencies, and ensure timely approvals
Job match score

Early Applicant

Key Skills

Location

Work Experience

1 – 5 Years

1 Vacancy

₹ 5-12 Lacs P.A

Mumbai(Andheri East)

Hybrid
Must have key skills
Coordination,Submission,module 1
Other key skills
CMC,Regulatory Submissions
Job description
What you’ll do
REQUIRE EXPERIENCE IN MODULE 1 COORDINATION AND SUBMISSIONS.

MAIN PURPOSE OF ROLE

Experienced professional individual contributor that works under limited supervision.

Applies subject matter knowledge in the area of Regulatory Affairs.

Requires capacity to apply skills/knowledge within the context of specific needs or requirements.

MAIN RESPONSIBILITIES

As the Experienced professional in the Regulatory Affairs Sub-Function, possesses well developed skills in directing development of product registration submission, progress reports, supplements, amendments, or periodic experience reports.
Interacts with regulatory agency to expedite approval of pending registration.
Serves as regulatory liaison throughout product lifecycle.
Participates in some of the following: product plan development and implementation, regulatory strategy, risk management, chemistry manufacturing control (CMC).
Ensures timely approval of new drugs, biologics or medical devices and continued approval of marketed products.
Serves as regulatory representative to marketing, research teams and regulatory agencies.
Advises development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations.
Industry type
Pharmaceutical & Life Sciences
Department
Customer Success, Service & Operations
Role
Operations – Other
Role category
Operations
Employment type
Full Time, Permanent
Education
Any Graduate

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Operations – Other, Mumbai

About company
Multinational healthcare company that develops and sells a range of nutritional products, medical devices, diagnostics, and branded generic medicines.

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