Regulatory Affairs Officer

1 day ago

Wagholi Pune Maharashtra, India Statistical Pharma Full time

**Regulatory Affairs Officer Duties & Responsibilities**

The role and function of a Regulatory Affairs Officer includes the following duties and responsibilities:

- Preparing submissions of licence variations and renewals to strict deadlines;
- Ensuring that a company’s products comply with regulations;
- Keeping abreast of international legislation, guidelines and customer practices in all countries that the company is exporting to;
- Negotiating with regulatory authorities for marketing authorisation;
- Specifying storage, labelling and packaging requirements.
- Collecting, collating and evaluating scientific data that has been researched by colleagues;
- Developing and writing clear arguments and explanations for new product licences and licence renewals;
- Planning and developing product trials and interpreting trial data;
- Advising scientists and manufacturers on regulatory requirements;
- Reviewing company practices and providing advice on changes to systems;
- Liaising with, and making presentations to, regulatory authorities;
- Monitoring and setting timelines for licence variations and renewal approvals;
- Working with specialist computer software and resources;
- Writing clear, accessible product labels and patient information leaflets;
- Providing strategic advice to senior management throughout the development of a new product;
- Project managing teams of colleagues involved with the development of new products;

**Salary**: ₹111,861.27 - ₹643,812.53 per year

**Benefits**:

- Internet reimbursement

Schedule:

- Day shift

Supplemental pay types:

- Performance bonus

Ability to commute/relocate:

- Wagholi, Pune, Maharashtra: Reliably commute or planning to relocate before starting work (required)

**Education**:

- Higher Secondary(12th Pass) (preferred)

**Experience**:

- total work: 1 year (preferred)

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