Regulatory Affairs Manager

Fiza HealthCare; Mumbai; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Fiza Healthcare is seeking a Regulatory Affairs Executive/Manager to oversee regulatory compliance for products in target markets, based in Andheri, Mumbai. The role involves preparing dossiers, coordinating submissions, and advising on regulatory strategy across cross-functional teams.

The ideal candidate will have hands-on dossier preparation experience, strong knowledge of CTD/ACTD formats, and the ability to manage multiple regulatory projects from registration to post-approval activities.

Qualifications

• 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.

Responsibilities

• Ensure compliance of company products with 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 new 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, 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.

Skills

Regulatory affairs

Dossier preparation

CTD/ACTD knowledge

Regulatory submissions

Project coordination

Job description

Regulatory Affairs Job Description

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 new 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.