Looking for pharma jobs in Gujarat? Brooks Steriscience Limited is hiring an experienced Regulatory Affairs professional in Vadodara. Explore this exciting opportunity to build your career in one of India’s growing pharmaceutical organizations. Find the latest pharmaceutical careers in India, QA jobs, QC jobs, production jobs, and walk-in interview updates on Pharma Recruiter.
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About the Company
Brooks Steriscience Limited is a trusted pharmaceutical company committed to empowering health through innovation, quality, and regulatory excellence.
The company focuses on developing and manufacturing high-quality pharmaceutical products while maintaining strict compliance with international regulatory standards.
With a strong emphasis on innovation, quality systems, and continuous improvement, Brooks Steriscience serves global healthcare markets through robust manufacturing capabilities and regulatory expertise.
The organization offers professionals an excellent platform to build long-term careers in a dynamic and compliance-driven environment.
Job Details
- Company Name: Brooks Steriscience Limited
- Position: Team Leader – Regulatory Affairs (API)
- Experience: 7–10 Years
- Qualification: B.Pharma / M.Pharma
- Location: Vadodara, Gujarat
- Work Type: On-site
Job Description
Brooks Steriscience Limited is seeking an experienced Regulatory Affairs professional for its API division.
The selected candidate will manage regulatory submissions, lifecycle activities, and compliance for various Rest of World (ROW) markets while collaborating with multiple internal departments.
Team Leader – Regulatory Affairs (API)
- Department: Regulatory Affairs – API
- Market: ROW (Rest of World)
- Role: Team Leader
- Experience: 7–10 Years
- Education/Qualification: B.Pharma / M.Pharma
Skills/Qualifications
- Strong Regulatory Affairs experience in ROW markets
- Expertise in CTD, eCTD, and ACTD submissions
- Knowledge of global regulatory requirements
- Experience with initial dossier submissions
- Deficiency response management skills
- Post-approval variation handling
- Lifecycle management expertise
- Regulatory documentation and dossier compilation
- Cross-functional coordination abilities
- Excellent communication and organizational skills
- Ability to manage regulatory trackers and databases
- Understanding of labeling requirements across regions
- Strong analytical and problem-solving skills
- Attention to regulatory compliance and documentation
Key Responsibilities
- Prepare regulatory dossiers for ROW markets.
- Compile CTD, eCTD, and ACTD submissions.
- Handle initial product submissions.
- Manage regulatory deficiency responses.
- Coordinate with QA, QC, R&D, and Manufacturing teams.
- Review regulatory documentation.
- Maintain submission trackers and databases.
- Process post-approval variations.
- Manage renewals and annual reports.
- Track regulatory approvals and timelines.
- Review product labeling requirements.
- Ensure global regulatory compliance.
Benefits/Perks
- Excellent career growth opportunities
- Exposure to global regulatory markets
- Learning-focused work environment
- Competitive compensation package
- Cross-functional collaboration
- Professional skill development
- Stable pharmaceutical organization
- Opportunity to work on international submissions
- Compliance-driven workplace culture
How to Apply
Interested candidates who meet the eligibility criteria should send their updated CV to:
Email: preeti.yadav@brookssteriscience.com
Verified Post
Verification: To confirm the legitimacy of this posting, you can view the original announcement on the Brooks career page.
For more verified pharma jobs, walk-in interviews, QA jobs, QC jobs, production jobs, and pharmaceutical careers in India, visit https://pharmarecruiter.in regularly.
Apply today and take the next step toward a rewarding Regulatory Affairs career with Brooks Steriscience Limited.
Why You Should Join
Brooks Steriscience Limited provides professionals with the opportunity to work in a globally focused regulatory environment where innovation, quality, and compliance are valued.
Employees gain exposure to international regulatory standards while collaborating with experienced cross-functional teams.
FAQs
Who is eligible to apply?
Candidates with B.Pharma or M.Pharma qualifications and 7–10 years of Regulatory Affairs experience in API are eligible.
How can I apply?
Interested candidates should email their updated CV to preeti.yadav@brookssteriscience.com.
Is this a walk-in interview?
No. This opportunity requires candidates to apply through the official email ID provided by the company.
What career growth opportunities are available?
The role offers exposure to global regulatory markets, international submissions, lifecycle management, and long-term career advancement within a compliance-focused pharmaceutical organization.
