Ra Manager

Role & responsibilities

• Lead and manage regulatory licensing activities for pharmaceutical products.
• Handle the preparation, review, and submission of regulatory dossiers to authorities.
• Ensure compliance with CDSCO, USFDA, EMA, TGA, MHRA, WHO, and other global regulatory bodies.
• Coordinate with internal teams, external regulatory agencies, and licensing partners.
• Stay updated on changes in regulatory guidelines and implement necessary changes.
• Support new product registrations, renewals, and post-approval changes.
• Assist in regulatory audits and inspections.

Requirements:

• Bachelors or Masters degree in Pharmacy, Life Sciences, or a related field.
• 7 to 10 years of experience in Regulatory Affairs & Licensing in the pharmaceutical industry.
• Strong knowledge of global regulatory requirements for drug licensing.
• Experience in regulatory submissions, dossier preparation, and handling regulatory queries.
• Excellent communication and stakeholder management skills.

Preferred Qualifications:

• Experience in generics, biologics, or specialty pharma.
• Familiarity with electronic submissions (eCTD).