Connote Healthcare Pvt Ltd
Website:
connotegroup.com
Job details:
Job Title: Regulatory Affairs Executive
Location: Ahmedabad, Gujarat
Experience Required: 6months - 2 Years
Industry: Pharmaceutical (Dermatology)
Company: Connote Healthcare Pvt. Ltd.
About the Role:
Connote Healthcare Pvt. Ltd. is seeking a detail-oriented and proactive Regulatory Affairs professional to join our dynamic team. The ideal candidate will be responsible for managing and coordinating all regulatory activities to ensure compliance with applicable regulations, facilitating product registrations, and maintaining updated regulatory documentation.
Key Responsibilities:
- Develop and implement regulatory strategies and plans for dermatology products.
- Prepare, review, and submit regulatory filings, including CTD, ACTD, ECTD, and product/country-specific dossiers.
- Maintain and update regulatory documents (dossiers, product permissions, COPP, etc.).
- Monitor, interpret, and analyse new and existing regulations to assess their impact on products and processes.
- Liaise with regulatory authorities and internal teams for smooth product approvals.
- Ensure timely submission of renewals, variations, and amendments.
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Qualifications & Skills:
- Bachelor’s/Master’s degree in Pharmacy, Life Sciences, or related field.
- 1–3 years of experience in regulatory affairs within the pharmaceutical industry, preferably dermatology.
- Strong knowledge of regulatory submission formats (CTD, ACTD, ECTD).
- Excellent communication, documentation, and organizational skills.
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