Executive/Sr Executive – Regulatory Affairs | Sun Pharma | Gurgaon

Job Description

Role & Responsibilities:

• This position will support and manage the regulatory activities associated with the Chemistry, Manufacturing, and Controls for New Drug Applications across the globe. Regulatory activities focus on filing activities/query responses/post-approval changes as suggested across the globe.
• The person will be responsible for assuring the established regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that timely and high-quality regulatory submissions are made.
• Understanding global regulatory requirements, particularly for US/EU/Japan/China and the rest of the markets and sharing additional data generation/gap assessments with CFT
• Closely work with consultants, partners, and local regulatory colleagues to understand regional requirements.
• Preparation of Agency consultation packages, briefing book, and required presentations and engaged with Agency for consultations
• Provide CMC support for other branded projects as needed.
• Additional duties include coordination with our global manufacturing sites, integration of regulatory strategy with those sites, and communication with senior management.
• Responsible for the preparation of IND and IMPD documents
• Providing consistent support to commercial and clinical teams.

Minimum requirements: Through regulatory knowledge and a good understanding of ICH, FDA, and EMA drug guidance.

Experience: 2 to 6 Years

Qualification: M.Pharma

Location:- Gurgaon