Regulatory affairs

Bharat Parenterals Ltd. is a Gujarat based pharmaceutical company, established in 1992 by Mr. Ramesh Desai, who started the company with a vision of making world class affordable medicines and to take it to the forefront of contract manufacturing units in Gujarat.

Exercises good judgment on regulatory, quality, and technical related compliance issues. High personal integrity; trustworthy; strong compliance and quality mind-set. Solution orientated, strong sense of ownership and accountability.

Leben Life Sciences Pvt. Ltd is an established pharmaceutical formulation company for more than four decades. LLS has following openings for its EU-GMP Approved Global Standard Formulation manufacturing facility at Akola

Contribute to preparation including authoring where relevant and delivery of simple, and with experience, increasingly more complex regulatory maintenance submissions from either a global and/or regional perspective.  Good understanding of regulatory guidelines, regulatory framework, including regional trends, for various types of applications and procedures.

Timely compile documents for license renewals, update and re-registrations. Review of technical documents like BMR. Stability protocol & report, specification and method of analysis, process validation protocol and report required for dossier compilation.

The candidate will be responsible for preparation and submission of dossiers for NCEs and NBEs and will present it to relevant internal and external stakeholders. The candidate will represent the company with Indian regulatory agencies, including CDSCO, RCGM, Central Bureau of Narcotics and Karnataka drugs control department.

CORONA Remedies Pvt. Ltd. Our journey started in 2004, with a commitment to creating a better quality of health for all by being at the forefront of research, manufacturing and marketing of high quality products.

The Senior Specialist, Expert License Management prepare dossiers and execute actions that support the license security and product compliance on the markets, and that meet companys and health authorities requirements. Encounter the challenges to enable representatives from all major disciplines involved to reach agreement on the license management strategy and approach.

B.Pharm / M.Pharm; Compile, review and timely submission of Deficiencies responses as received from Health Canada. Support Cross-functional team like Analytical Development, Formulation Development during product development and align documentation as per HC guidelines.