Hikal Limited Hiring Regulatory Affairs Assistant Manager

Hikal Limited Recruitment, Assistant Manager in Regulatory Affairs

Are you an experienced professional in regulatory affairs looking for a new opportunity? Hikal Limited, a leading player in the API industry, is hiring an Assistant Manager for their Regulatory Affairs department. If you have 6-8 years of relevant experience and are ready to take on new challenges, this could be the perfect role for you. This position is open for locations across India.

Position: Regulatory Affairs Assistant Manager

Key Responsibilities:

• Hands-on experience on New Drug Master File / Active Substance Master File to various Agencies (US, Europe, Health Canada, Japan, etc.,).
• Hands-on experience on life cycle maintenance to Drug Master File / Active Substance Master File to various Agencies (US, Europe, Health Canada, Japan, etc.,).
• Hands-on experience on responses to queries received from various Agencies.
• Hands-on experience on customer support for their ANDA approvals in various markets.
• Hands-on experience in change management system with respect to regulatory perspective.

Qualifications:

• Education: Bachelor’s or Master’s degree in Pharmacy, Chemistry, or a related field.
• Experience: 6 to 8 years of hands-on experience in regulatory affairs within the API industry.
• Skills:
  • Comprehensive knowledge of regulatory guidelines and submission processes for multiple regions.
  • Strong analytical and problem-solving skills.
  • Excellent communication and interpersonal abilities.
  • Detail-oriented with a focus on accuracy and compliance.

Why Join Hikal Limited?

Hikal Limited is a well-established company known for its commitment to excellence in the pharmaceutical industry. Joining Hikal means being part of a dynamic team that values innovation and quality. This role offers opportunities for professional growth and the chance to work on impactful projects in a supportive environment.

How to Apply

If you meet the qualifications and are excited about this opportunity, please send your updated resume to ramya_n@hikal.com.