Executive Regulatory Affairs

1 week ago

Surat, India Trident Lifeline Pvt. Ltd. Full time

**Job Description & Responsibilities.**
- Ensure that a company's products comply with the regulations of the regions where they want to distribute them.
- Keep up to date with national and international legislation, guidelines, and customer practices
- Collect, collate, and evaluate scientific data from a range of sources Develop and write clear arguments and explanations for new product licenses and license renewals Prepare submissions of license variations and renewals to strict deadlines.
- Monitor and set timelines for license variations and renewal approvals work with specialist computer software and resources write clear, accessible product labels and patient information leaflets plan and develop product trials and interpret trial data to advise scientists and manufacturers on regulatory requirements.
- Provide strategic advice to senior management throughout the development of a new product
- Review company practices and provide advice on changes to systems liaise with, and make presentations to, regulatory authorities
- negotiate with regulatory authorities for marketing authorization

**Position**: Executive - Regulatory Affairs

**Department**: Regulatory Affairs

**Qualification**: He/She must have a B.Pharm/M. Paharm.

**Experience**: 2 to 3 years of experience in the **Pharmaceutical Regulatory department **and good exposure to the **pharmaceutical industry**. Should be sound with the new development and good experience over various countries.

**Job type**: Full Time

**Job Location**: Surat

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

**Benefits**:

- Paid sick time
- Provident Fund

Schedule:

- Day shift

Ability to commute/relocate:

- Surat, Gujarat: Reliably commute or planning to relocate before starting work (required)

**Experience**:

- total work: 2 years (required)

Work Location: In person

**Speak with the employer**
+91 9016134492

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