Executive/Senior Executive/Manager/Senior Manager - Regulatory Affairs - Chemistry Manufacturing & Controls

Executive/ Sr. Executive/ Manager/ Sr. Manager - Regulatory Affairs

Title : : Chemistry Manufacturing and controls

Position : Executive/ Sr. Executive/ Manager/ Sr. Manager

Experience : 3-12 yrs

Location : Chennai

Kindly find below the job details :

The primary responsibility is development and execution of CMC strategies initiated prioritized post approval changes globally in collaboration with the CMC GRL.

Reviews proposed changes for completeness and accuracy and development of initial global regulatory strategy while considering registered content and seeks endorsement by the CMC GRL.

Reviews technical/supportive information for submission to support change, reviews and applies pertinent global regulatory guidelines and develops technical justification of change for agency submission

Flags identified risks to the CMC GRL and/or appropriate leadership

Represents GEPRA CMC point of view and meets with key stakeholders to resolve challenges.

Supports Query and/or commitment management in collaboration with CMC GRL.

Essential requirements:

1.Preparation and submission of responses to the queries from Regulatory Agencies / parties / customers.

2.Co-ordination with external Regulatory Agencies for regulatory submissions and approvals.

3.Review and submission of responses to the queries from Regulatory Agencies

4.To prepare the schedule for Dossier submission and monthly report submission( Target vs Achieved )

5.Preparation and Organizing of ANDAs, dossiers for submission to US / EU / Japan markets as per the respective regulatory guidelines.

If above job role and requirement matches your profile then apply or call at 044-26512967