Lupin Hiring Freshers Regulatory Affairs
- B.Pharm RA Officer Vacancy at Lupin Santacruz
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities
- Additional Expectations
- Eligibility / Qualifications
- Education
- Relevant Courses (comma-separated)
- Experience
- Skills & Competencies
- Location & Salary
- Application Process
- FAQs
- Is this role open to freshers?
- Do I need previous RA experience?
- What type of submissions will I support?
- Is this a full-time role?
- Are soft skills important for this role?
- Summary Table
B.Pharm RA Officer Vacancy at Lupin Santacruz
Apply for Regulatory Affairs Officer roles at Lupin Santacruz. B.Pharm graduates with 0–1 year experience eligible.
Lupin is hiring fresh graduates and early professionals for the Regulatory Affairs Officer position at its Santacruz location. This role is well-suited for candidates who want to build a career in regulatory submissions, dossier compilation, and compliance activities. If you have a pharmacy or chemistry background and are eager to contribute to global regulatory processes, this is a strong entry point into the RA domain.
Company Overview
Lupin is one of India’s leading pharmaceutical companies with a global footprint across formulations, APIs, biotechnology, and specialty products. The company focuses on high-quality manufacturing, regulatory excellence, and innovation-driven operations. Its regulatory teams support global submissions, lifecycle management, and product compliance across major international markets.
Job Role & Responsibilities
The Regulatory Affairs Officer will support submission-related tasks and documentation activities for market approvals and lifecycle management.
Key Responsibilities
- Prepare and submit Annual Reports and supplements in alignment with regulatory timelines
- Support New Product Launch documentation and regulatory requirements
- Assist with submission of labeling amendments and updates
- Prepare and submit responses to DRL (Discipline Review Letters) and IR (Information Requests)
- Provide support for Complete Response Amendments
- Assist with dossier compilation and documentation collation
- Ensure compliance with quality guidelines and regulatory standards
- Maintain records, trackers, and submission documentation as per SOPs
Additional Expectations
- Ensure accuracy and completeness of submitted documentation
- Coordinate with internal teams for data collection and clarification
- Contribute to timely and efficient submission processes across projects
Eligibility / Qualifications
Education
- Graduation in Pharmacy (B.Pharm)
- Master’s degree in Chemistry (preferred)
Relevant Courses (comma-separated)
B.Pharm, M.Pharm, M.Sc Chemistry, Pharmaceutical Regulatory Affairs Certification, Quality Assurance Courses.
Experience
- Fresher to 1 year of experience
- Exposure to dossier compilation or awareness of quality guidelines preferred
Skills & Competencies
- Customer Centricity
- Strategic Agility
- Collaboration & Stakeholder Management
- Attention to detail and documentation accuracy
- Innovation and problem-solving
- Strong communication skills
- Result-oriented mindset
Location & Salary
- Location: Santacruz, Mumbai, Maharashtra
- Work Model: On-site
- Salary: As per Lupin standards for entry-level RA roles
Application Process
Interested candidates can apply through Lupin’s official career portal.
Apply Here: https://careers.lupin.com/job/Santacruz-Officer-RA-MH/1344352600/
Candidates should upload an updated resume highlighting:
- Academic qualifications
- Any exposure to regulatory submissions
- Coursework or training in RA or QA
FAQs
Is this role open to freshers?
Yes. Freshers with strong academic foundations in pharmacy or chemistry can apply.
Do I need previous RA experience?
Not mandatory. Awareness of dossier compilation or regulatory guidelines is preferred.
What type of submissions will I support?
Annual reports, supplements, labeling amendments, DRL/IR responses, and regulatory documentation.
Is this a full-time role?
Yes. This is a full-time RA Officer position based in Santacruz.
Are soft skills important for this role?
Yes. Documentation accuracy, communication, and collaboration are essential.
Summary Table
| Category | Details |
|---|---|
| Company | Lupin Pharmaceuticals, Santacruz |
| Vacancies | Regulatory Affairs Officer |
| Required Education | B.Pharm, Master’s in Chemistry |
| Experience | Fresher to 1 year (dossier compilation awareness preferred) |
To apply for this job please visit careers.lupin.com.
