Executive - IRA

Job Title

Executive Regulatory Affairs - India

R&D1 Regulatory Affairs

G12A

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, youll 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 others journeys.

Evaluation of regulatory documents, compilation of dossier and submissions to CDSCO-HQ/CDSCO-Zonal offices for regulatory approval of drug substance and drug products.

• Evaluation of regulatory strategies for products to be registered in India
• Review of CMC & other documents, coordination with cross functional teams for necessary corrections, preparation of cover letter of application & other regulatory documents, compilation of regulatory dossier and submission on the portal of regulatory authority for obtaining,
• CT, BE and domestic manufacturing and marketing permission
• Import & marketing approval in India
• Compilation of IPC testing dossier and coordination for sample readiness and submission to laboratory
• Post approval changes
• Phase IV CT applications
• Additional site notification/approval
• BE permission for export registration
• permission to manufacture drugs for examination, test or analysis in Form CT-10/12/13
• permission to import drugs for examination, test or analysis in Form-11/Form CT-17
• permission to import drugs in Form 8.
• Checking artworks of product label and coordinate for necessary corrections

Graduate : M.Pharm

Tenure : 3 years of relevant experience

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. Lets create a brighter future together!

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).

We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.