Executive - Regulatory Affairs

Job Title:

Executive – Regulatory and Business Continuity

Business Unit:

R&D1 Regulatory Affairs

Job Grade

G12A

Location :

Baroda

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: 

• Compilation , review  of dossier for US , EU , AU, Canada & IL market for both solid oral and non-oral dosage form


• Review of query response prepared and compiled by regulatory associates


• Manage all the activities pertaining to dossier submission for aforesaid markets .


• Meet the dossier submission and query response timeline as per given target


• Review of all the documents received from stake holder for  dossier compilation , Query response and Life cycle management


• Allocation of projects to regulatory associate & manage the team for all the  regulatory submission activities


• Lifecycle management for US , EU, Canada & IL market


• Single point contacts for all the regulatory submission activities for IL and Palestine markets

Travel Estimate

NA

Job Requirements

Educational Qualification

M.Pharm

Experience

Tenure: 2 – 4 yrs.

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).