Unison Pharmaceuticals - Assistant Manager - Regulatory Affairs

About the job:

We are under screening process for Regulatory Affairs professionals

Company Name : Unison Pharmaceuticals Pvt Ltd.

Location : Ahmedabad, Gujarat

Experience: 7-10 years

Designation : Sr. Executive/AM - Regulatory Affairs

About Company :

Unison Pharmaceuticals Private Limited (Formerly known as Unison Pharmaceuticals) was established in 1981 with a vision of providing quality & most affordable medicines across the nation.

With 4 decades of medical service to the society, Unison is today one of the fastest growing company in Gujarat State.

The base of operation being a single state, the company has very strong footing in the market.

The company strictly believes in ethics and moral values throughout the operations of the business.

Role and responsibilities:

- Responsible for preparing/reviewing various regulatory documents for Emerging markets (South East Asia, Africa, CIS, Latin America, Gulf Countries) such as,

- Dossiers in ACTD, CTD and in country specific format.

- Variation filling, renewal fillings, Query response, Site registration applications, Tender fillings.

- Legal Applications related to local FDA\CDSCO like FSC, COPP, Product permissions, WHO GMP inclusions.

- Responsible for coordinating with Cross functional teams for timely receipt of technical documents.

- To verify and approve all technical documents in line with current regulatory requirements.

- Regulatory assessment of CCN/Deviation for Impact assessment.

- Artwork development, amendments and maintenance without adversely affecting the business continuity to implement regulatory changes.

- Maintain various regulatory status.

- Monitoring of product lifecycle as per regulatory requirement.

- Literature search, data collection, evaluation to meet the requirement of above job responsibilities.

Candidate should have detailed knowledge on:

- Regulatory requirements for submission of product dossiers.

- Registration samples submission in ROW countries.

- Candidate must have Good in written and verbal communications.

- Candidate must have basic knowledge of Microsoft Word, Excel & Power Point