Regulatory Affairs Assistant Manager

The Pharma Patashala

10 - 12 years

10 - 15 Lacs

raichur

Posted:8 hours ago| Platform:

Apply

Skills Required

gap analysis global regulatory affairs regulatory strategy dossier preparation cms decision making problem solving

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

1. Regulatory Strategy & Submissions

Develop and implement
regulatory strategies
for new product development and existing product life cycle management.
Review and approve
dossiers (CTD/eCTD/ACTD)
for submissions in domestic and international markets.
Manage
new drug applications (NDA), ANDA, IND, DMF, variations, renewals, and post-approval changes
.
Ensure timely filing of submissions to
DCGI, CDSCO, US FDA, EMA, MHRA, WHO, TGA
and other authorities.

2. Compliance & Quality

Ensure all products comply with
local and international regulations, ICH, GMP, and pharmacopoeial standards
.
Review and approve
labeling, artwork, and packaging materials
for compliance.
Stay updated with
regulatory guidelines, circulars, and notifications
, and communicate changes to senior management.
Support
regulatory audits and inspections
by providing accurate documentation.

3. Team & Cross-Functional Coordination

Lead, guide, and mentor
RA executives and associates
in preparing submissions.
Coordinate with
R&D, QA, QC, production, supply chain, and marketing
to gather required documents/data.
Act as a liaison between the company and
regulatory authorities
for queries, clarifications, and deficiency responses.

More Jobs at The Pharma Patashala

Sekhmet(optimus)-Production ,Engineering production

Chennai

Experience: Not specified

INR 3 - 5 Lacs

Sekhmet(Optimus)- Quality control , Microbiology

Chennai

3.0 - 8.0 yrs

INR 3 - 8 Lacs

Production Chemist

Hyderabad

2.0 - 6.0 yrs

INR 3 - 6 Lacs

Production Chemist

Hyderabad

2.0 - 6.0 yrs

INR 3 - 6 Lacs

Research And Development Chemist

Hyderabad

2.0 - 5.0 yrs

INR 3 - 6 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.