Job Description

Key Responsibilities -

1. Regulatory Guidelines & Strategy

Monitor and interpret

local/international regulations

for

APAC, LATAM, ROW, and Emerging markets

. Stay updated with

FDA, ICH, WHO

and country-specific guidelines for

LATAM & Middle East

.

2. Dossier Preparation & Submission

Prepare and submit

registration dossiers (Checklist/CTD/ACTD)

and

market-specific documents

. Support

new product, variation, and renewal submissions

; ensure document accuracy and completeness. Coordinate with

regulatory agencies

to obtain timely approvals and handle queries.

3. Documentation & Compliance

Maintain

regulatory databases

, track

dossier progress and query

, and ensure

version control

. Collaborate with

R&D, QA, QC, Sourcing, and BD

teams to ensure lifecycle compliance. Implement

GMP and QMS

principles and support

audits and internal reviews

.

4. Communication & Coordination

Act as a

contact point

for

RTM Group of Companies

and manage document flow. Participate in

meetings with internal teams, clients, or authorities

to support regulatory planning. Review

administrative dossier parts

(forms, declarations, LOAs, agreements) and

Confidentiality/Supply Agreements

.

5. Consulting & Business Development Support

Identify potential

clients for regulatory services

and assist in preparing

tenders, proposals, and presentations

. Contribute to expanding the company's

regulatory consulting presence

in emerging markets.

6. Artwork, Samples & Reporting

Prepare and review

artworks for packaging and labeling

and coordinate

printing approvals

. Manage

product samples

for submissions or exhibitions. Assist in

PMS and PSUR

report preparation and monitor

market feedback

and regulatory updates

Skills & Competencies -

o

Knowledge of CTD/ACTD dossier formats and global regulatory standards.

Strong documentation, coordination, and organizational skills. Excellent communication, analytical, and problem-solving abilities. Skilled in regulatory tracking tools, multitasking, and meeting deadlines. Proven ownership and accountability in completing submissions.

Other Important Requirements -

Attention to detail with a strong sense of responsibility. Ability to work independently as well as in a team environment. Willingness to learn and adapt to evolving regulatory requirements.
Job Type: Full-time

Pay: ₹300,000.00 - ₹700,000.00 per year

Application Question(s):

* Do you have experience into pharmaceutical sector?