Executive - Regulatory Affairs

Fresher Mpharm/Bpharm ( preference Mpharm)

Communication Written : English

Speaking : English, Hindi, Telugu

Typing : Medium to High

Software Knowledge : MS office

You will be handling independent customer service with our clients

Responsibilities:

Responsible for providing support and regulatory guidance to a team in the completion of projects supporting regulatory submissions.

Responsible for the preparation and review of quality regulatory submissions for various markets to ensure timely approval.

Responsible for the maintenance and timely completion of regulatory documents to support regulatory compliance in various markets.

Accountable for assessment, coordination and compilation of deficiency responses in a timely manner.

Works with other functional areas to resolve issues related to information for regulatory submissions.

Evaluate, prepare and review of post-approval supplements to manage the regulatory product life-cycle as applicable.

Assessment of change control documents. Review of change control forms and provide accurate assessment for change being assessed (as applicable and assigned).

Maintenance of regulatory databases to ensure accuracy of information. Maintain established trackers and ensure accuracy of information.

Co-ordinate with third party manufacturers for document requirement for regulatory submissions.

Act as a back-up for team members and support as & when required.

Timely communication and follow-up with the respective departments for compilation and submissions and query responses to meet agreed timeline.

Interpret and ensure compliance with SOPs, RA policies & procedures and regulatory guidelines. Prepare and/or draft SOPs and regulatory guidelines (as applicable).

Interact with other applicable departments to discuss and provide solutions to regulatory issues and/or problems.

Communicate with external sources such as agents and suppliers to request and/or provide data relevant to submissions.

Works in a safe manner collaborating as a team member to achieve all outcomes.

Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.

Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.

All other relevant duties as assigned.