Senior Executive- India Regulatory Affairs

SUN PHARMA

Vadodara

On-site

INR 1,500,000 - 2,500,000

Full time

12 days ago

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Job summary

Sun Pharma in Baroda seeks a Manager II – India Regulatory and Business Continuity to lead regulatory strategy for Indian registrations within the R&D1 Regulatory Affairs unit. This role requires collaborating with cross-functional teams and ensuring compliance across dossiers and submissions in India.

The candidate will review CMC, CT/BE documents, and trial data, prepare SEC executive summaries, and file applications on SUGAM.

Qualifications

Graduate: Masters (M-Pharm) in relevant field.
Experience 8-10 years in regulatory affairs.
Strong knowledge of India's regulatory guidelines.

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.

Skills

Regulatory Affairs

Cross-functional coordination

Leadership

Education

Masters (M-Pharm)

Job description

Job Title

Manager II – India Regulatory and business Conitnuity

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.

Travel Estimate

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).

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