Regulatory Affairs Associate

5 hours ago

Goregaon Mumbai Maharashtra, India Zivira Labs Private Limited Full time

_**Regulatory Affairs Associate**_

As regulatory affairs associate you'll be the crucial link between the company, its products and regulatory authorities. You'll combine your knowledge of scientific, legal and business issues to ensure products, which are developed or manufactured, meet the required legislation.

**Products include**:

- Pharmaceuticals
- Veterinary medicines
- Nutraceutical products
- Food supplements

**Job description**
- Assess submission documentation in consideration and compliance with the regulatory requirements and to provide inputs to cross functional teams.
- Interact and communicate effectively with regulatory agencies and external parties to facilitate approvals and address queries. Represent the company in regulatory meetings and negotiations
- Support due diligence process pre-filing and implement action plan to address deficiencies.
- Handling of Deficiency letters from regulatory authority s until product approval
- Ensure compliance with relevant regulations and guidelines, staying abreast of changes in regulatory requirements. Provide guidance to internal teams on regulatory matters.
- Create and maintain regulatory documentation, such as regulatory strategies, technical files, and regulatory impact assessments. Ensure accurate and timely record-keeping.
- Escalate key issues to management (risk of delays to submissions, risk to approvability, complex supporting data requirements)
- Assist submissions team with CMC related m1 administrative documentation.#
- Conduct internal audits to assess regulatory compliance and identify areas for improvement. Implement corrective and preventive actions as needed.
- Regulatory Support for the product development

**Skills**

Education: Bachelor's or advanced degree in pharmacy (regulatory field)

Experience: Experience in regulatory affairs within the specific industry (pharmaceuticals, nutraceuticals, food supplements, etc.)

Regulatory knowledge: In-depth understanding of regulatory requirements and processes of various countries

Communication skills: Strong written and verbal communication skills for effective interaction with internal teams and regulatory agencies

Attention to detail: Meticulous attention to detail in preparing regulatory documents and ensuring compliance

Problem-solving: Ability to analyze and solve complex regulatory issues, providing creative and compliant solutions

Adaptability: Flexibility to navigate evolving regulatory landscapes and adapt strategies accordingly

Teamwork: Ability to work collaboratively in a cross-functional team environment

Project Management: Effective organizational and project management skills to meet regulatory deadlines.

**Salary**: ₹500,000.00 - ₹700,000.00 per year

**Benefits**:

- Health insurance
- Life insurance
- Provident Fund

Schedule:

- Day shift

**Experience**:

- total work: 1 year (preferred)

Ability to Commute:

- Goregaon, Mumbai, Maharashtra (required)

Ability to Relocate:

- Goregaon, Mumbai, Maharashtra: Relocate before starting work (required)

Work Location: In person

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