Manager 2- Formulation Development Non Orals

Job Title:

Manager-2 - FR &D Non-Orals (Compliance group)

Business Unit:

R&D1 Regulatory Affairs

Job Grade

G11A

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.

• Review documents required for regulatory submissions across global markets, including product development reports and scientific justifications for responding to regulatory queries.


• Evaluate and review documents related to technology transfer to ensure accuracy and regulatory compliance.


• Review protocols and reports for various product development studies of Non-Oral products to ensure scientific soundness and regulatory alignment.


• Review documents required for drug-device combination products in accordance with applicable regulatory requirements.


• Review filter validation reports and conduct risk assessments for extractables and leachables, elemental impurities, and nitrosamine impurities.


• Prepare and review Standard Operating Procedures (SOPs) and internal guidelines to ensure system compliance.


• Review investigation reports related to failures, Out of Specification (OOS), and Out of Trend (OOT) results, and support root cause analysis.


• Ensure adherence to internal quality systems and regulatory standards & conduct SOP training.

Travel Estimate

NA

Job Requirements

Educational Qualification

M Pharm

Experience

Tenure

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!

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