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.'

Job Description

• 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 : 9-11 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).

Skills Required

Quality Systems, Technology Transfer, Regulatory Submissions, Root Cause Analysis