Senior Executive - Regulatory Affairs

Job Title

Regulatory and Business Continuity

Business Unit

R&D1 Regulatory Affairs

Job Grade

G11B Senior Executive

Location :

Halol Gujarat

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

• Participates in activities related to new product registration/ new filing, re-registration, queries of regulatory agency and variation filing.
• Coordination with CRA, ADD, FDD, MSTG and PMO for regulatory requirements related to registration, re-registration, queries, and variation filing.
• Product life cycle management, change control evaluation and decision for final variation category followed by approval of change control in track wise system.
• Annual report: Details to be provided to QA for new registration filing details along with variation filing and approval details for respective countries.
• Preparation of CPID and Approval package, Co-ordination with corporate regulatory and plant team for impact analysis of proposed change against approved package and filing of variation whenever applicable.
• Review and approval of stability protocols, new product introduction forms, repackaging forms, stability discontinuation note and plan deviation (Whenever applicable) etc.
• Activities related to variation management - Tracking of variation filing, approvals and intimation to plant for implementation of changes.
• Arrangements of registration samples for regulatory submission purpose in ROW market.
• Circulation of regulatory approval and commitment details to plant team.
• Test License and Product permission procurement and management.
  
  

Travel Estimate

NA

Job Requirements

Educational Qualification

M. Pharm/ B. Pharm

Experience

Tenure : 4 – 10 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