Executive - RA EM

SUN PHARMA


Date: 3 weeks ago
City: Vadodara, Gujarat
Contract type: Full time
Job Title

Executive – Regulatory & 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.”

Job Description

  • Preparation of registration strategy for Brazil submission
  • Adequate understanding on respective authority guidance and filing of new product and post approval changes
  • Review of documents related to product registration and dossier submission leading to faster approval
  • Prepare response to deficiency letter received from Anvisa, Brazil
  • Maintain life-cycle (PCH) / post approval changes for drug product registration dossiers including timely circulation of approval information
  • Provide regulatory support to cross functional department
  • Adequate assessment of change control as per regulatory guidance
  • Prepare and submit scientific advice to Anvisa, Brazil

Travel Estimate

NA

Job Requirements

Educational Qualificatio

Graduate : M.Pharm

Experience

Tenure : 1-2 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).

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