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 proce

📌 Regulatory Affairs Associate Goregaon
🏢 Zivira Labs Private
📍 Goregaon