Associate - CSCC & RM (Regulatory Operations)

M/s Gi Human Resources And Services

1 - 5 years

5 - 12 Lacs

mumbai

Posted:1 month ago| Platform:

Apply

Skills Required

coordination submission module 1 cmc regulatory submissions

Work Mode

Hybrid

Job Type

Full Time

Job Description

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.

More Jobs at M/s Gi Human Resources And Services

Hiring For Loan Sales Profiles In a Leading Finance Company

noida, ghaziabad, delhi / ncr

Experience: Not specified

INR 1 - 2 Lacs

Head Quality Management System

gurugram

15.0 - 22.0 yrs

INR 22 - 30 Lacs

Hiring For Loan Sales/Home Loan Profiles In a Leading Finance Company

noida, ghaziabad, delhi / ncr

Experience: Not specified

INR 1 - 2 Lacs

Urgent Hiring For Brand Ambassador In a Reputed Beer Brand - Gurugram

noida, faridabad, gurugram

Experience: Not specified

INR 2 - 3 Lacs

Hiring For Relationship Officer/Collection Officer In Bandhan Bank

bardhaman, hooghly, burdwan

Experience: Not specified

INR 1 - 2 Lacs

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.