Regulatory Affairs Officer
1 week ago
**Vacancy**: For Regulatory affairs officer
**Job description**
**Roles and Responsibilities**
2) To check artworks for regulated/ semi regulated countries.
3) To co-ordinate for documents and samples for regulatory submissions with manufacturing locations LL & TP
4) Handling of queries pertaining to regulatory submissions from various regulatory authorities.
5) Maintain and update regulatory archives and Regulatory Database of the identified countries.
6) To arrange IMC & country embassy of legal documents.
7) Any other work assigned by Regulatory Head/Technical Head as required
8) Local FDA activity & CDSCO activities as and when required
9) Handling specific Projects like New products/ SOPs/ BE initiation etc
**Experience**:2 to 3 years of Regulatory filing experience.
**Job Specific Skills**:Regulatory filing experience Preferably CTD Dossier filing & knowledge on Registration Guidelines / ICH regulations
**Other desirable Skills**:Multi-tasking capabilities w.r.t regulatory related work
**Languages Known**: English is Mandatory
**Role Pharmacist**
**Industry Type**: Pharmaceutical & Life Sciences
**Functional Area**: Healthcare & Life Sciences
**Employment Type**: Full Time, Permanent
**Education**
B.Pharma
**Key Skills**
regulatory affairs
CTD regulatory submissions
**Salary**: ₹300,000.00 - ₹400,000.00 per year
Schedule:
- Day shift
Ability to commute/relocate:
- Mumbai - 400104, Maharashtra: Reliably commute or planning to relocate before starting work (required)
**Education**:
- Bachelor's (preferred)
**Experience**:
- total work: 2 years (required)
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