Senior Manager Regulatory Affairs

3 days ago

Gurugram, India upGrad Rekrut Full time

Job Location: GURGAON


Qualification: MSc/ PHD


Experience: 10+ Years in Agrochemicals / Biologicals /Chemicals


Job Summary:



1. Develop and implement regulatory strategies and plans to support the development, registration, and commercialization of biological products in various global markets.

2. Ensure that regulatory submissions, including but not limited to INDs, BLAs, and post-approval submissions, are in compliance with relevant regulations and are of the highest quality.

3. Serve as the primary point of contact for regulatory agencies and lead interactions, meetings, and negotiations with regulatory authorities.

4. Keep abreast of changes in regulatory requirements and guidelines and advise internal teams on potential implications and necessary actions.

5. Provide regulatory guidance and support to cross-functional teams, including R&D, clinical, quality, and commercial teams, to ensure alignment with regulatory requirements and expectations.

6. Conduct regulatory assessments and gap analyses to identify potential issues and develop risk mitigation plans.

7. Collaborate with internal and external stakeholders to ensure that regulatory milestones and objectives are met on time and within budget.

8. Manage and mentor a team of regulatory affairs professionals, providing leadership, guidance, and support to ensure high performance and professional development.


Qualifications:

1. Bachelor’s degree in a scientific or related field; advanced degree preferred.

2. A minimum of 8 years of regulatory affairs experience in the biopharmaceutical industry, with a focus on biological products.

3. Strong understanding of regulatory requirements and guidelines, including FDA and EMA regulations.

4. Proven track record of successful regulatory submissions and interactions with regulatory agencies.

5. Excellent communication, leadership, and project management skills.

6. Ability to work effectively in a cross-functional team environment and influence decision-making.

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