Regulatory Affairs Executive Preferred Pharma

2 weeks ago

Mumbai, India Sneha Medicare Private Limited Full time

**Job Title : - Executive Regulatory Affairs - Pharma (Permanent - Full Time)**

Job Description:
- We are looking for an Executive Regulatory Affairs in Pharma Industry.

**Roles and Responsibilities**

1) To prepare dossiers for product registration, renewal, as per the requirements for registration purposes.

2) To check artworks for regulated/semi-regulated countries.

3) To co-ordinate documents and samples for regulatory submissions with manufacturing locations LL & TP

4) Handling queries pertaining to regulatory submissions from various regulatory authorities.

5) Maintain and update regulatory archives and Regulatory databases 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) Preparation done as per the CTD guidelines.

9) Handling specific Projects like New products/ SOPs/ BE initiation etc.

**Qualification : -**
- Minimum qualification is required at least Graduation.

**Experience : - **At least 2-3 yrs. of experience is required. Relevant industry exp is required.

**Requirements and skills**
- Understanding of both legal and scientific matters
- The ability to grasp new concepts quickly and to assimilate and evaluate scientific data
- Analytical and problem-solving skills
- Written and oral communication skills
- Attention to detail
- Strong negotiation skills
- IT skills, particularly in relation to using databases and familiarity with commercial software
- The confidence to report to management
- Teamworking skills and the ability to lead and motivate others
- Project-management skills
- Integrity and a professional approach to work.

**Behaviour : -**
- Person should be proactive
- Ability to take decision
- Take initiative
- Has problem solving attitude.
- Has good communication skills.

**Working Knowledge - Tools: -**

Having research experience is valuable, as is knowledge of:

- Clinical work
- Toxicology
- Pharmaceuticals
- Medical devices
- Manufacturing techniques
- Relevant aspects of the law.

**Working Days : - **Monday to Saturday10.30 am to 7.00 pm

**Job Types**: Full-time, Regular / Permanent

**Salary**: ₹15,000.00 - ₹30,000.00 per month

Schedule:

- Day shift

Supplemental Pay:

- Yearly bonus

COVID-19 considerations:
All customer requiered to wear mask, all surface should be sanitize regulaorly and Vaccination is required.

**Experience**:

- total work: 1 year (required)

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