Regulatory Affairs

Job Title: Regulatory Affairs Executive / Manager

Job Location: Andheri, Mumbai

Industry: Pharmaceutical / Healthcare

Company: Fiza Healthcare

Website: www.fizahealthcare.com

Candidate Preference: Male Only

Key Responsibilities

- Ensure compliance of company products with applicable national and international regulatory requirements in target markets.
- Monitor and stay updated on regulations, guidelines, regulatory changes, and customer requirements.
- Prepare and review regulatory dossiers, documents, samples, and submission materials for product registrations and tenders.
- Collect, compile, evaluate, and organize scientific and technical data from various sources for regulatory submissions.
- Prepare and maintain regulatory dossiers in CTD / ACTD formats as per market requirements.
- Manage regulatory submissions, including current registrations, variations, renewals, and post-approval activities.
- Track submission timelines and ensure timely completion of registrations, renewals, variations, and regulatory approvals.
- Draft and review product labels, packaging materials, Patient Information Leaflets (PILs), and other regulatory documents.
- Provide regulatory guidance and support to Country Sales Managers and business development teams.
- Provide regulatory inputs and strategic advice to senior management during new product development and product launch.
- Coordinate with cross-functional teams including R&D;, Quality, Production,



Medical, Marketing, and Business Development.
- Conduct and manage internal regulatory audits and recommend corrective actions where required.
- Review existing regulatory processes and company practices and recommend improvements to ensure continued compliance.
- Liaise with regulatory authorities and support regulatory meetings, presentations, and queries.
- Coordinate with the Marketing team regarding Marketing Authorization, registration data, submission status, and approvals.
- Review and provide regulatory approval for packaging, promotional materials, advertising, and marketing concepts prior to product launch.
- Maintain accurate and updated records of regulatory submissions, approvals, commitments, and product registrations.

Required Skills & Experience

- Experience in Regulatory Affairs / Pharmaceutical Regulatory Affairs.
- Hands-on experience in Regulatory Dossier preparation and submission.
- Good knowledge of CTD / ACTD dossier formats.
- Understanding of product registration, variations, renewals, and post-approval regulatory activities.
- Knowledge of national and international pharmaceutical regulatory guidelines.
- Strong documentation, coordination, communication, and analytical skills.
- Ability to manage multiple regulatory projects and timelines.
- Experience in dealing with regulatory authorities and cross-functional teams will be an advantage.

📌 Regulatory Affairs Manager (Mumbai)
🏢 Fiza Healthcare
📍 Mumbai