Regulatory affairs

Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products

Role is responsible for implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations, guidances and defined regulatory strategies.

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.