Senior Executive- India Regulatory Affairs

Sun Pharmaceutical Industries, Inc.; Vadodara; On-site; INR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Robust benefits

Opportunities for personal growth

Collaborative work environment

Job summary

A global pharmaceutical company is seeking a Senior Executive for India Regulatory Affairs in Vadodara. The ideal candidate will have 8-10 years of regulatory experience, focusing on product registration in India. Key responsibilities include evaluating regulatory strategies, coordinating with teams for required documentation, and preparing submissions. An M-Pharm degree is required. Join us to create a brighter future in pharmaceutical care.

Qualifications

• 8-10 years of experience in regulatory affairs.
• Expertise in evaluating regulatory strategies for product registration in India.
• Proficiency in coordinating with cross-functional teams.

Responsibilities

• Evaluate regulatory strategy for product registration.
• Coordinate with Cross Functional Team for filing documents.
• Review CMC documents for regulatory submissions.
• Review specifications for bulk drugs and formulations.
• Prepare rationales on safety and efficacy of drugs.
• Search literature per application strategy.
• Prepare safety/efficacy rationales referencing published literature.
• Prepare executive summaries for SEC referrals for drugs not approved in India.
• Obtain final CMC/CT/BE documents from cross functional team and compile dossier for submission.
• File ND/SND/FDC applications on SUGAM portal for domestic permissions.
• Review draft specimen or label and carton.
• Prepare prescribing information referencing international sources.

Skills

Regulatory strategy evaluation

Cross-function team coordination

CMC document review

Specification review

Clinical trial document review

Literature search

Rationale preparation

Dossier compilation

Application filing on SUGAM

Prescribing information preparation

Education

Masters (M-Pharm)

Job description

Title: Senior Executive- India Regulatory Affairs

Location: Tandalja - R&D

Company: Sun Pharmaceutical Industries Ltd

Manager II – India Regulatory and business Continuity

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.”

Key Responsibilities

• To evaluate regulatory strategy for products to be registered in India.
• To co-ordinate with Cross Functional Team for getting various documents required for filing the product in India.
• Responsible for reviewing CMC documents to be submitted in dossier as per regulatory guidelines.
• To review specification for bulk drug and formulations as per regulatory expectation.
• Responsible for reviewing clinical trial and bioequivalence study documents to be submitted in regulatory applications.
• To search literature through various websites as per the application strategy.
• To prepare rationale on safety and efficacy of new drug/FDC by referring published literature.
• To prepare executive summary for SEC referral for drugs not approved in India.
• To get all final CMC/CT/BE final documents from cross functional team and compilation of dossier for regulatory submission.
• To file ND/SND/FDC application on SUGAM portal for getting domestic manufacturing and marketing permission / clinical trial permission etc.
• To review draft specimen or label and carton.
• To prepare prescribing information by referring international prescribing information.

Job Requirements

Educational Qualification

Graduate : Masters (M-Pharm)

Experience

Tenure : 8-10 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).