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Position: Regulatory Affairs Executive – Domestic (DCGI)
Department: Regulatory Affairs
Location: Vadodara – Corporate Office
Market Focus: Domestic
Experience Required: 2–4 years
Qualification: B.Pharm / M.Pharm
Salary: Open & Negotiable (based on skills & experience)
Company Website: www.exemedpharma.com
About Exemed Pharmaceuticals
At Exemed Pharmaceuticals, we are committed to innovation, quality, and compliance in the pharmaceutical industry. Our Regulatory Affairs team plays a critical role in ensuring that our products meet all regulatory standards while delivering safe and effective medicines to patients. We are now seeking a detail-oriented, proactive, and knowledgeable Regulatory Affairs Executive to join our domestic market (DCGI) team.
Core Responsibilities
- Regulatory Submissions:
- Manage and prepare submissions for Mfg. & Mkt. applications ∗∗CT−21/CT−18∗∗**CT-21 / CT-18**∗∗CT−21/CT−18∗∗ for IND, New Drug, Subsequent New Drug, and FDC approvals.
- Handle applications for CT-05 / CT-04, CT-10 / CT-12 / CT-13, and Import Licenses ∗∗CT−16/Form12/Form08∗∗**CT-16 / Form 12 / Form 08**∗∗CT−16/Form12/Form08∗∗.
- Prepare Form 29 applications and IPC submissions.
- Regulatory Documentation:
- Develop presentations for Subject Expert Committee (SEC) meetings.
- Manage product lifecycle from approval to post-marketing regulatory requirements.
- Technical Preparation:
- Compile Module 4 & 5 (Nonclinical & Clinical data) for dossiers.
- Prepare Pack Inserts (PI), Patient Information Leaflets (PIL), and Summary Product Characteristics (SPC).
- Conduct literature searches for nonclinical, clinical, and formulation data.
- Draft product monographs and various rationales (FDC, efficacy, dosing).
Knowledge & Skills Required
- Proficiency with SUGAM portal and CDSCO website operations.
- Strong understanding of BABE guidelines, Clinical Trial Phase III guidelines, and Animal Toxicology studies.
- Excellent written and verbal communication skills for interacting with regulatory authorities and internal stakeholders.
- Strong attention to detail, analytical thinking, and ability to work under deadlines.
Why Join Us?
- Be part of a growing pharmaceutical organization with a focus on innovation and compliance.
- Work in a collaborative corporate environment at our Vadodara head office.
- Gain exposure to domestic regulatory processes and interact with leading industry experts.
- Competitive compensation package with scope for career growth.
📩 How to Apply
Send your CV to recruitment@exemedpharma.com with the subject line:
Application – Regulatory Affairs Executive (Domestic – DCGI)
Interested candidates please reach us via email: recruitment@exemedpharma.com
📅 Applications will be processed on a rolling basis — apply early for priority consideration.
