Job Description

Designation - Junior Regulatory Affairs

Job Roles and Responsibility -

1. Dossier Making ,Compilation, Review & Submission:

- Thoroughly Dossier making , review, compile, and critically assess

comprehensive regulatory dossiers (e.g., CTD Modules 1-5, ANDAs, MAAs,

country-specific formats) for generic pharmaceutical products to ensure accuracy,

completeness, and compliance.

- Coordinate the collection and review of all necessary documentation (e.g., CMC

data, preclinical/clinical reports, administrative documents) from internal

departments such as R&D, Quality Assurance, Production, Analytical

Development, Clinical, and Business Development.

- Ensure all submissions are complete, accurate, and fully compliant with the

target health authority's specific regulations and guidelines (e.g., ICH, US FDA,

EMA, Health Canada, ANVISA, etc.).

- Manage the submission process, including electronic submissions (eCTD) where

applicable.

2 Regulatory Maintenance & Lifecycle Management:

- Prepare and submit responses to health authority queries (deficiency letters,

requests for information) in a timely and comprehensive manner.

- Manage post-approval changes by preparing and submitting variations,

amendments, supplements, and renewals for existing product registrations.

- Maintain accurate and up-to-date regulatory databases and tracking systems for

all submissions, approvals, and ongoing commitments.

- Ensure all regulatory documentation is meticulously archived in accordance with

company policies and regulatory requirements.

3 Artwork Review & Approval:

? Critically review and approve packaging artwork components (e.g., cartons,

labels, inserts, patient information leaflets, blister foils) to ensure strict adherence

to the content of the approved regulatory dossier and relevant health authority

requirements.

? Verify the accuracy of all textual and graphical elements, including product name,

strength, dosage, active ingredients, excipients, warnings, storage conditions,

manufacturer details, and regulatory symbols.

? Collaborate closely with Marketing, Production, Quality Assurance, and the

Design Team to facilitate the timely and compliant implementation of new or

revised artwork.

4 Regulatory Intelligence & Compliance:

? Monitor and interpret new and evolving global and local regulatory guidelines,

regulations, and industry best practices relevant to generic pharmaceutical

products.

? Assess the impact of new regulations on ongoing and future projects and

communicate findings to relevant stakeholders, including the Portfolio Team.

? Contribute to the development and maintenance of internal standard operating

procedures (SOPs) related to regulatory affairs.

? Support regulatory inspections and audits by providing necessary documentation

and explanations.

5 Cross-functional Collaboration & Strategy:

? Act as a key regulatory contact point for various internal departments, including

R&D, Manufacturing, Quality, Business Development, Portfolio Team,

Marketing, and Supply Chain, providing regulatory guidance and support

throughout the product lifecycle.

? Participate in project team meetings, offering regulatory input and contributing to

strategic discussions, particularly concerning new product introductions and

portfolio expansion.

Job Type: Full-time

Pay: ₹12,000.00 - ₹22,000.00 per month

Benefits:

Health insurance Provident Fund
Work Location: In person