HomeRegulatory AffairsManager Regulatory Affairs | Hikal Ltd | Bengaluru

Manager Regulatory Affairs | Hikal Ltd | Bengaluru

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Established in 1998 Hikal offers solutions across the life sciences value chain. We provide world-class active ingredients, intermediates, and R&D services to global pharmaceuticals, animal health, biotech, crop protection, and specialty chemical companies.

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Advanced chemistry and cutting-edge technology converge at Hikal. Our ecosystem facilitates seamless collaboration amongst employees at all levels across the company. Hikal is a learning experience for new recruits as well as senior professionals. Our culture of continuous learning is nurtured by a Scientific Advisory Board of distinguished Global chemists, which enables you to improve problem-solving skills and innovate at a molecular level.

More importantly, Hikal empowers and rewards deserving talent. The work environment is underpinned by processes to enhance the performance and productivity of the enterprise. At the same time, our policies encourage innovation and individual creativity.

We are looking for a Manager of Regulatory Affairs having experience in the Pharma (API / Bulk drugs) industry.

Designation: Manager – Regulatory Affairs

Location: Jigani, Bengaluru, Karnataka,

Job Description:

  • Provide technical support to R&T during the development phase of API with respect to regulatory requirements
  • Ensure Pharmacopoeia compliance of API as per the timeline 
  • Reviewing change controls, Method validation reports, Specifications, and other technical documents with respect to regulatory requirements 
  • Co-ordinate and support the on-time submission of Agency response. 
  • Evaluate and track the filing of Amendment/variation with respect to the cost improvement process 
  • Reviewing change controls, Method validation reports, Specifications, and other technical documents. 
  • Coordinating, evaluating, and submission of regulatory dossiers (Drug Master Files/ CEP Dossiers)for registration (new submissions) with various regulatory authorities and maintaining the life cycle management.

Desired Candidate Profile:

  • The candidate must have working experience in the pharma industry.

Salary: Negotiable

Contact Details:

Ms. Roopa Shivakumar

roopa_sivakumar@hikal.com, hr@hikal.com

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