Regulatory Affairs Executive

10 hours ago

Mumbai Maharashtra, India R. Wadiwala Sec Pvt Ltd Full time

Designation : Regulatory Affairs Specialist
- Qualifications : Bachelor's degree in a scientific discipline, such as pharmacy, biology, or

chemistry
- Experience : Minimum 2-5 years of experience in regulatory affairs
- Salary : Good Hike on Current CTC
- Location : Sandhurst Road Mumbai - Head office
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- Job Summary:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The

requirements for our products, managing the submission process for regulatory

approvals, and maintaining up-to-date knowledge of regulatory changes.Essential Duties and Responsibilities:
Regulatory Compliance: Ensure company products comply with relevant regulatory requirements,

such as USFDA, FDA, EMA, and local regulations.

Submission Management: Prepare and submit regulatory documents, such as INDs, NDAs, and

MAAs, to regulatory agencies.

Software: Good knowledge about regulatory software’s like, Pharmareddy, eCTD Global, Educe

Solution.

Competency: Thorough knowledge in filling DMF/Master files/Submissions to countries like USA,

Europe/UK, Canada, Australia, Brazil, GCC, Jordan, Switzerland, South Africa, Ukraine, Tunisia,

Singapore

Login/Account Creation: Having knowledge to make Company Login/Account Creation on all

Countries Regulatory Portals.Regulatory Strategy: Develop and implement regulatory strategies to support product

development and commercialization.

Regulatory Intelligence: Stay up-to-date with changing regulatory requirements and provide

guidance to internal stakeholders.

Audits and Inspections: Coordinate and manage regulatory audits and inspections.Labeling and Advertising: Review and approve product labeling and advertising materials for

regulatory compliance.

Regulatory Agency Interactions: Communicate with regulatory agencies, such as the FDA, to

address questions and concerns.

Regulatory Documentation: Maintain and manage regulatory documents, such as regulatory

submissions, approvals, and correspondence.

Document Preparation: having knowledge about or can solo prepare all the Regulatory

Training and Guidance: Provide regulatory training and guidance to internal stakeholders.

Compliance Monitoring: Monitor company activities for complianceSkills:

- Must have good knowledge of Regulatory Submissions
- Must have good knowledge of Regulatory Research
- Must be familiarity with chemical industry specific regulations and guidelines.

Pay: ₹40,000.00 - ₹50,000.00 per year

Schedule:

- Day shift

**Experience**:

- in regulatory affairs: 2 years (preferred)

Work Location: In person

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