Designation : Manager - Regulatory Affairs

Role : Head - Regulatory Affairs

Functional Area : Regulatory Affairs

Education : BSc, / MSc - Chemistry, BE - Chemical / Biotech

Industry Type : API

Experience : 8 -15 Years

Compensation : Negotiable

Location : Limbasi

Job Description

• Working knowledge of US, EU, Brazil, Japan, Russia, Korea & Row Market.
• Preparing Dossiers for registration of products in various markets.
• DMF Preparation, review and submission according to latest requirements.
• Knowledge in regulatory affairs, eCTD and regulatory guidance.
• Filing of amendments & lifecycle management as per requirement.
• Co-ordination with cross functional departments for documents required for regulatory submission.
• Post approval changes and its filing & deficiency responses to various regulatory authorities.
• Good understanding of regulatory regulations, standards and guidance documents.
• Review, compilation and submission of new marketing authorization application.
• Review of DMF & pharmaceutical development reports for regulatory submissions.