Regulatory Affairs Officer

6 days ago


Pitampura, India Maiden pharmaceutical Full time

**Designation - Regulatory Executive/Sr. Executive/Regulatory Manager**

Experience - 2 to 4 years

**Job Description : -**

Prepare ACTD and CTD regional dossiers

Preparation and review of dossiers as per the current prescribe guidelines of respective regulatory authorities.

Preparation of registration and renewal dossiers.

Review and approval of artwork for different countries.

Review of technical documents like (BMR/MFR/PV/AMV) required for dossier.

Preparation /Review of clinical trials/PSUR & TOXICIY studies.

**Essential Skills and Abilities**
- Analytical skills
- Strong communication skills, both verbal and written
- Strong interpersonal skills
- Proficiency on excel, word, power point and other software skills

**Salary**: From ₹500,000.00 per year

**Benefits**:

- Cell phone reimbursement

Schedule:

- Morning shift

Ability to commute/relocate:

- Pitampura, Pitampura - 110034, Delhi: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 3 years (preferred)

**Speak with the employer**

+91-XXXXXXXXXX


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