Regulatory Affairs Officer

2 days ago

Mumbai Maharashtra, India Glendale Biomed Pvt. Ltd Full time

**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 (required)

**Experience**:

- total work: 2 years (required)

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