Sr. Officer - Regulatory Affairs, CDMO Partner For Derma

Greetings! & very warm welcome to BEST-FIT Recruitment Riders,

highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors.

professional career opportunity

Please see the following position summary:

• Client Name: Preferred CDMO Partner for Ophthalmic & Derma products for global markets.

• Position: Officer / Sr. Officer - Regulatory Affairs

• Department:

  Regulatory Affairs

• Location: Mumbai

Job Profile:

• To ensure timely preparation, compilation, and submission of high-quality regulatory dossiers for Rest of the World (ROW) markets in compliance with respective country regulatory requirements and internal quality standards, supporting product registration, renewal, & product life cycle management.
• Prepare, review, & compile registration dossiers (CTD / ACTD / country-specific formats) for ROW markets such as LATAM / Latin America, Africa, ASEAN, GCC countries etc.
• Ensure dossiers are prepared as per the latest regulatory guidelines & submission requirements of respective countries.
• Support regulatory submissions for new product registrations, renewals, & variations.
• Provide regulatory support & technical assistant to sub-ordinate for new product registrations, renewals, & variations.
• Address regulatory queries / deficiencies received from different regulatory authorities or business partners within defined timelines.
• Review of ODMF of API.
• Follow-up & review queries related to ODMF.
• Gather & organize documentation required for tenders & complete relevant questionnaires accurately.
• Review of all technical data to ensure document compliance and to reduce quality error.
• Ensuring the upkeep of regulatory databases.
• Coordinate with internal teams to prepare appropriate technical justifications & responses.
• Co-ordination & follow up with F&D, ADL, Manufacturing, Packing, QC, QA team for getting all the necessary documents.
• Coordinate for the arrangement & dispatch of product samples, working standards & other material required for registration.

Desired Profile:

• B.Pharm / M.Pharm (Life Sciences / Pharmaceutical Sciences) with 2 to 4 years of experience Regulatory Affairs (ROW Markets-Latin America, ASEAN, African countries, GCC, India, etc.

• Strong understanding of CTD / ACTD formats and country-specific regulatory requirements for ROW markets.

• Experience in dossier preparation for ROW / Semi-Regulated / Emerging markets.

• Familiarity with regulatory submissions for oral solid and topical dosage forms.
• Stay updated with changing regulatory requirements in ROW markets.
• Good coordination, communication, and documentation skills.
• Attention to detail and ability to manage multiple projects simultaneously.
• Proficiency in MS Office and regulatory databases.

Recruiter's Contact Details:

BEST-FIT Recruitment Riders

G-7, Amrit Complex, R.V. Desai Road,

Near Goyagate Circle, Vadodara-390001, Gujarat

Mobile: 07226009222, 09722042906

E-Mail: hrd@bfrr.in

Website: www.bestfitrecruitment.co.in