Manager - Corporate Relations

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

• Understanding of various types of applications on Online Portal.

• Knowledge about the various types of applications filed on the Online ODLS portal for Telangana and ONDLS portal.

• Knowledge about the various application forms and submission checklist.

• Able to prepare various types of applications and manage the submission on online portal.

• Hands on experience for tracking of applications on Online portal and able to discuss the same with the local regulatory authority.

• Co-ordination with the local regulatory authority for various types of approvals.

• Able to co-ordinate with the local regulatory authority about the strategy for the filed applications.

• Able to co-ordinate with CFT members regarding the updated requirement/ information received from local authority.

• Regular follow up with the local regulatory authority for the various types of inspections, query response and approvals.

• Co-ordination with local regulatory authority for the various types of inspections.

• Dealing with the local regulatory authority for getting the approvals in time.

• Arranging for the regular updates in case of any changes in regulations of local regulatory authority.

• Maintenance of regulatory database and records for all types of licences.

• Keeping the detailed records of all license including approval letters, inspection letters, query/compliance response.

• Preparing and sharing periodic status reports related to pending applications and approvals.

• Periodic visit to regulatory office (sFDA and CDSCO).

• Reasonable understanding of regulatory guidelines: NDCT Rules, ICH, WHO, Schedule M, Schedule L etc.
• Familiarity in dossier preparation for Oral / Non-orals / Biologics.
• Fair understating of requirement of Indian regulators for grant of various approvals.
• Good communication, and ability to convince regulators.
• Project coordination skills, with sense of prioritization.
• Ability to manage multiple projects and deadlines independently.
• Ability to make relationship and coordination skills.