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Senior Regulatory Affairs Consultant

2 months ago

New Delhi, India Outsized India Private Limited Full time

At Outsized, we match clients in financial services and management consulting to high-quality independent consultants and boutique/specialist firms for the execution of their key projects.

Our client, a global consulting firm, is working on a transformation project for a leading client in the pharma industry.

To support on this initiative, they are seeking a seasoned professional with experience in pharmaceutical regulatory affairs in the Indian market. The consultant will be supporting a crucial regulatory initiative aimed at ensuring compliance with Indian pharmaceutical regulations.

The project aims to strengthen the client's regulatory compliance framework in India, and possibly other international markets. Success will be measured by the timely and accurate completion of regulatory documentation, alignment with industry standards, and the client's ability to navigate the regulatory landscape more efficiently.

Key responsibilities:

- Provide expert guidance on pharmaceutical regulatory affairs, focusing primarily on Indian regulations

- Review and ensure compliance of the company's practices with regulatory requirements

- Support the preparation and submission of regulatory documentation to relevant authorities

- Assist in interpreting and applying regulatory changes and updates to the company's operations

- Collaborate with cross-functional teams to ensure alignment with regulatory strategies

- Report directly to the project lead, ensuring timely updates and clarity on all regulatory matters

- Contribute to ongoing projects that might extend to regulatory practices in other countries, leveraging global regulatory knowledge if applicable

Your background:

- 5 to 15 years of experience in pharmaceutical regulatory affairs, with deep knowledge of Indian regulatory practices

- Nice to have: Experience with regulatory frameworks in other countries, particularly in Asia or Europe

- Strong communication skills, with the ability to collaborate in a fast-paced, cross-functional environment

- This role requires on-site presence in Delhi for the duration of the engagement, which is initially set for three months, with potential extensions based on performance.

(ref:iimjobs.com)