Regulatory Cmc

Year Gurgaon, Haryana, India

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This position will support and manage the regulatory activities associated with the Chemistry, Manufacturing and Controls for New Drug Applications across globe. Regulatory activities focus on filing activities/query responses/post approval changes as suggested across globe.
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 rest of 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 engage 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 to senior management.
Responsible for preparation of IND and IMPD documents
Providing consistent support to commercial and clinical teams.

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