Title:  Executive - Global Regulatory Operations - Branded

Job Title:

Executive

Business Unit:

Global Clinical Operation

Job Grade

G12A

Location :

Gurgaon/Mumbai

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.”

Key responsibilities:

Position               :  Executive

Grade                   :  G12A

Job Location       :  Gurgaon (preferable)/Baroda/Mumbai

Education            :  M.Pharm

Department       :  Regulatory & Business Continuity - Branded

Candidate shall be responsible for assuming the role for the assigned specialty programs (NCE/BLA) who shall be responsible for regulatory operations activities including but not limited to CTA applications(in EU, LATAM , USA, Canada, ROW) , CTIS management, submission management, eCTD publishing of all modules, document management etc. Must understand and be updated with current Global Regulatory filing requirements and eCTD /CTIS structure.

• Collaborate with Strategists (Leads) and coordinators for submission strategy and timelines.
• Prepare Regulatory Management Plan, Submission content plan for CTA
• Manage lifecycle of CTA for all in-house and outsourced activities
• Be the critical technical coordinator for Clinical Trial Application submission and notification/ Request for Information/Information request ensuring accurate and timely input of data
• Archival of necessary submissions and/or documents
• Assist with definition, development and implementation of processes to meet the evolving CTIS need
• Track, generate metrics as requested by the Functional Head from time to time
• Implement best practices, participate in process improvements / enhancement
• To support other Regulatory operations activities including, but not limited to, Clinical Trial Disclosure, eCTD publishing

Travel Estimate

20%

Job Requirements

Educational Qualification

M.Sc / B.Pharm / M.Pharm

Experience

Tenure:  1 to 3 Years

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).