Regulatory affairs

Support Cross-functional team like Analytical Development, Formulation Development during product development and align documentation as per HC guidelines and Extend support for any other Regulatory related Function.

Demonstrated knowledge and understanding of CCDSs, US and EU labeling, and the dynamics of Labeling Team purpose and objectives 

Preparation, review and submission of Dossiers. Good exposure on Life Cycle Management. Handling Post approval & Pre approval

PharmD/MS in a scientific discipline or equivalent education and related experience. Masters degree in RA/QA discipline, a plus.

Academic degree in Pharmacy MPharm or PhD, with preferably specialization in Regulatory Affairs or Pharmaceutics.

KLM Laboratories, our mission is to improve the lives of people around the world through innovative skincare/healthcare solutions

M.Pharm, B.Pharm, M.Sc ; Create new markets and clients in international business, drive sustainable business growth, manage product registrations, and follow up on orders and collections. Implement sales targets, plan budgets, and maintain strong client relationships and records.

Drafting and formatting product labels, packaging inserts, cartons, and leaflets according to regulatory and corporate guidelines.

Developing India-specific Artwork, Support to Regulatory dossier preparation and submissions like New drug applications, Site registration, Clinical trials and Import licence. Managing Registration samples right from dispatch of samples till the report.