Unison Pharmaceuticals Private Limited was established in 1981 with a vision of providing quality and most affordable medicines across the nation. With more than 4 decades of medical service to the society, today Unison is one of the fastest growing company in India. In addition to this, the company is ranked 82 among top companies of India (Rupee wise sales) MAT March 2020.
Vacancy details:
- Department : Regulatory Affairs – ROW Market (Sr. Officer/ Exe/ Sr. Exe/ AM)
- Qualification: M. Pharmacy / B. Pharmacy
- Experienced: 2 – 7 years
- Salary: ₹Not Disclosed
Job Description: Greeting from Unison Pharmaceuticals. !!!!!
- Important Details :
- Location: Ahmedabad( Vastrapur )
- Post of date:27/06/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to face
- Interview Rounds of Interview: HR
Job description
Unison Pharmaceuticals, one of the fastest growing organization is looking for Sr. Officer/Executive/Sr. Executive/Assistant Manager to join our Regulatory Affairs – ROW Market market.
Key Accountabilities/ Responsibilities
1. 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.
2. Monitoring of product lifecycle as per regulatory requirement.3. 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.
Interested candidates may also email their resume to [email protected]
