Job Description

Job Title:
Sr. Executive / Manager-Regulatory Affairs / Liaisoning
Job Grade:
G11B/G11A
Function:
Corporate Relations
Location:
Delhi
Key Responsibilities
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?
As you enter the Sun Pharma world, you'll find yourself becoming 'Better every day' through continuous progress. Exhibit self-drive as you 'Take charge' and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we 'Thrive together' and support each other's journeys."
Position Summary:
We are looking for a skilled and detail-oriented Sr. Executive / Manager Regulatory Affairs / Liaisoning to join our dynamic team at our Delhi location. The ideal candidate will be responsible for supporting in preparing, compiling, reviewing and submitting high-quality regulatory dossiers for Oral Solid Dosage (OSD), Non-Oral Dosage forms and Biologics for the Domestic market (India) in accordance with regulatory requirements.
Key Responsibilities:

• 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).

Desired Candidate Profile:

• 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.

Job Requirements
Educational Qualification
B. Pharma and M. Pharma
Experience
4 to 6 years of work experience
Your Success Matters to Us
At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let's create a brighter future together!
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

Skills Required