Unison Pharmaceuticals Pvt Ltd Recruitment November 2020.Unison Pharmaceuticals Private Limited (Formerly known as Unison Pharmaceuticals) was established in 1981 with a vision of providing quality and most affordable medicines across the nation.
Important Vacancy details:
- Post Name: Regulatory Affairs (Europe Market)
- Education: B.Pharm, B.Sc, M.Sc, M.Pharm
- Experienced:03 to 6 years
- Location: Ahmedabad( Moraiya )
- Address: Unison Pharmaceuticals Pvt. Ltd. Unit – II, B– 6, Steel Town, Opp. CIL Nova Petro, Behind HOF, Moraiya, Taluka : Sanand, Ahmedabad – 38 22 13.
- Salary :NA
- Openings :NA
Note:If Intrested Candiadtes Send Updated Resume Below Email id.
Job Description: We have requirement for the post of Regulatory Affairs (Europe Market) in Unison Pharmaceuticals Pvt Ltd !
Key Accountabilities/ Responsibilities
- Work on variety of Regulatory related submissions
- Ensure timely authoring and submission of dossiers (Module 2-5) for regulated regions such as Europe, Australia, South Africa, New Zealand and Canada in the eCTD format including familiarity with publishing activities.
- Preparation of quality responses to the deficiency letters from various agencies within agreed time frame.
- Co-ordinate with various departments to obtain essential scientific data and documents required for dossier preparation and query responses.
- Involve in review of source documents for in-house: product development report, specification (excipients, API and finished product), manufacturing batch record, analytical method, validation report, validation protocol etc.
- Actively participate in the evaluation of regulatory compliance of document/product/ process/test methods changes.
- Identification of correct change code and authoring of variation package to maintain product life cycle in a timely manner.
- Provide regulatory insights and support for contract manufacturing projects (CMO/CDMO).
- Preform gap analysis for extension of dossier to other territories as per country specific requirements.
- Identifies and communicates risks and issues impacting project progression.
- Assist in the development of Regulatory CMC strategies for assigned products and projects.
- Update/Maintenance of database with regulatory submission and approval.
- Any other regulatory activity as per the business needs.
For all the positions, candidates should also have sound knowledge cGMP documentation and must be familiar with cGMP requirements.
Interested candidates may also email their resume to email@example.com
Selection Process: The selection will be on the basis of Interview.