Company: Amogen Pharma Pvt. Ltd.

Department: Regulatory Affairs

Experience: 6–8 Years

Location: Karkapatla, Telangana

Industry: Pharmaceutical / API / Biotechnology

Employment Type: Full-Time

We are looking for an experienced Regulatory Affairs professional with 6–8 years of relevant pharmaceutical industry experience. The candidate should have strong expertise in regulatory submissions, dossier preparation, regulatory compliance, product registrations, and coordination with regulatory authorities and internal departments.

Key Responsibilities

- Prepare, review, compile, and submit regulatory dossiers and documentation for pharmaceutical/API products.
- Manage regulatory submissions for India and international markets, as applicable.
- Prepare and review CTD/eCTD dossiers, ACTD and other country-specific submission formats.
- Coordinate preparation of regulatory documents with R&D;, QA, QC, Manufacturing, Engineering, Analytical, and other departments.
- Review technical documents, specifications, analytical data, stability data, validation documents, and manufacturing information for regulatory submissions.
- Handle new product registrations, variations, renewals, amendments, and post-approval changes.
- Respond to queries, deficiency letters, and requests for additional information from regulatory authorities.
- Track regulatory submissions, approvals, renewals, commitments, and timelines.
- Maintain regulatory databases, submission trackers, and product registration records.
- Ensure regulatory documents are prepared and submitted within defined timelines.
- Monitor applicable regulatory guidelines,



notifications, and changes in pharmaceutical regulations and assess their impact on the organization.
- Support regulatory inspections and provide required regulatory documentation.
- Coordinate with external consultants, regulatory agents, and international partners where required.
- Ensure compliance with applicable GMP and regulatory requirements.
- Review artwork, labels, packaging materials, product information, and promotional/technical materials from a regulatory perspective.
- Support preparation of responses to regulatory observations and inspection findings.
- Maintain proper documentation and regulatory archives.
- Provide regulatory guidance to cross-functional teams during product development and commercialization.

Required Technical Skills
- Strong knowledge of Pharmaceutical Regulatory Affairs.
- Excellent knowledge of CTD/eCTD dossier compilation and submission requirements.
- Good understanding of ICH guidelines and applicable regulatory requirements.
- Knowledge of USFDA, EMA, MHRA, WHO, CDSCO, and other regulatory authorities is preferred.
- Experience in product registration, renewals, variations, amendments, and post-approval activities.
- Strong understanding of GMP,



Quality Systems, Stability, Validation, and pharmaceutical manufacturing processes.
- Ability to review and interpret technical and regulatory documents.
- Strong knowledge of regulatory submission procedures and documentation requirements.
- Good experience in handling regulatory authority queries and deficiency responses.
- Proficiency in MS Office, Excel, Word, and regulatory documentation systems.

Educational Qualification
- M.Pharm / B.Pharm / M.Sc. in Pharmaceutical Sciences, Chemistry, Life Sciences, or a relevant discipline.
- Additional qualification/certification in Regulatory Affairs will be an advantage.

Experience
- 6–8 years of relevant experience in Pharmaceutical Regulatory Affairs.
- Candidates with strong hands-on experience in regulatory submissions and dossier management will be preferred.
- Experience in API / pharmaceutical manufacturing / biotechnology products will be an added advantage.

Key Competencies
- Strong regulatory knowledge and analytical ability
- Excellent documentation and report-writing skills
- Strong attention to detail
- Good communication and interpersonal skills
- Cross-functional coordination
- Ability to manage multiple regulatory submissions simultaneously
- Strong follow-up and deadline-management skills
- Problem-solving and decision-making ability
- Ability to work independently as well as within a team

Pay: ₹45,000.00 - ₹65,000.00 per month

Perks

- Food provided
- Health insurance
- Paid sick time

Work Location: In person

📌 Regulatory Affairs -Senior Executive (Uparpalli)
🏢 Amogen Pharma
📍 Uparpalli