Regulatory Affairs Specialist

Position : Regulatory Affairs Specialist

Department : Regulatory Affairs

Location : Ahmedabad

Key Responsibilities

• Plan and manage development of high-quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements
• Preparation, and compilation of dossiers for Regulated, Semi regulated, and ROW markets.
• eCTD publishing support with tool deployment
• Review of dossiers as per updated Country specific guidelines including Gap Analysis
• Attending and solving queries of dossier assessment.
• Lead & support CMC aspects of dossier to review and approve submission documents in accordance with the regulatory guidelines, evaluate changes in CMC documentation with respect to its impact on regulatory submissions, strategize filing categories, compile submissions to Europe, FDA, and other international markets.
• Due Diligence support on CMC strategy for complex injectable products.
• Experience in CMC requirements for EU/US for solid dosage forms and/or complex injectable.
• Coordinate with internal and external stakeholders and compile high quality regulatory submissions, within stipulated timelines and accordance to the guidelines, ensuring submission documents are accurate, compliant, and high-quality.
• Participation in regulatory meetings with Health Authorities.
• Other duties as assigned.

Qualifications & experience required

• Pharmacy Graduate or Post-Graduate
• Minimum 3-6 years of regulatory Affairs Experience.
• Experience for US & EU Market are preferred skills

Note: Immediate Joiners with experience in US Regulatory will be preferred.