Symbio Generrics India Pvt. Ltd., a specialized Active Pharmaceutical Ingredients (API) manufacturer, is hiring a Regulatory Affairs Executive for its head office in HSR Layout, Bangalore, Karnataka. Founded in 2010 by ex-Biocon professionals, Symbio operates USFDA, GMP, and GLP-certified facilities in Bangalore and Visakhapatnam, with ₹100–500 Crore revenue.
Rated 3.5/5 on AmbitionBox (22 reviews), it scores 3.3/5 for work-life balance but 2.9/5 for career growth due to slow appraisals. The role offers ₹4–7 Lakhs per annum (AmbitionBox estimates). Apply by May 20, 2025, to join a leader in API excellence
Application Details
- Location: Symbio House, No. 1215, 24th Main, 11th Cross, 1st Sector, HSR Layout, Bangalore, Karnataka 560102
- Application Method: Email CV and portfolio to careers@symbiogenerics.com, subject: “Regulatory Affairs Executive – Bangalore.”
- Deadline: May 20, 2025
- Contact: careers@symbiogenerics.com, +91-80-4121-8300
- Website: www.symbiogenerics.com
Notes:
- Fraud Alert: Symbio does not charge fees. Verify via www.symbiogenerics.com.
Why Join Symbio Generrics?
Symbio’s Bangalore R&D center in Jigani and manufacturing units (VPL Chemicals, Bangalore; Achutapuram, Vizag) produce APIs like Ursodeoxycholic Acid and Pregabalin, serving 60+ countries. Awarded Best API Company at ET Healthworld RE Pharma Awards 2024, it boasts no USFDA 483s in 2024. Rated 3.7/5 for salary, it faces criticism for post-resignation delays (e.g., final settlements). Join India’s $24.4 billion pharma export market, growing at 10% CAGR (Invest India).
Job Position: Regulatory Affairs Executive (National)
Seeking a detail-oriented professional to manage regulatory submissions and compliance for API manufacturing at Symbio’s Bangalore head office.
Job Details
- Department: Regulatory Affairs (National)
- Position: Executive
- Qualification: B.Pharm, M.Pharm
- Experience: 2–3 years in regulatory affairs (CDSCO, DCD, WHO-GMP, COPP)
- Vacancies: ~2–3 expected (based on industry norms)
- Location: HSR Layout, Bangalore
- Work Mode: On-site, desk-based with occasional travel within India
- Employment: Full-time
Responsibilities
- Compile documentation for site/product manufacturing licenses, test licenses, WHO-GMP, and COPP certifications at DCD/CDSCO across Bangalore and Vizag facilities.
- Prepare and submit NDA/SND applications at CDSCO (HQ), ensuring compliance with D&C Act.
- Coordinate with business partners for product registration and Form-10 documentation with CDSCO.
- Compile and submit documentation for Veterinary Health Certificates and GMP approvals at AQCS office.
- Align documentation with regulatory guidelines, plan submissions with R&D/QA/QC/Manufacturing teams, craft deficiency responses, and track approval progress.
- Build regulatory relationships to secure licenses, GMPs, and facilitate inspections; communicate clearly with stakeholders.
- Update databases for requests, submissions, and approvals; ensure timely task execution.
- Collaborate with technical teams (R&D, QA/QC, Manufacturing) to address customer queries and technical documentation for projects/products.
Required Skills and Qualifications
| Category | Details |
|---|---|
| Education | B.Pharm, M.Pharm |
| Experience | 2–3 years in regulatory affairs (API-focused, CDSCO/DCD, WHO-GMP, COPP) |
| Technical Skills | Compilation of NDA/SND, Form-10, DMF; knowledge of D&C Act, 21 CFR Part 11 |
| Regulatory Knowledge | CDSCO, DCD, WHO-GMP, COPP, Veterinary Health Certificates, GMP approvals |
| Soft Skills | Communication (written/verbal), data analysis, teamwork, time management |
| Preferred Expertise | Deficiency response crafting, cross-functional coordination, eCTD exposure |
Why This Role?
- Impactful Work: Streamline regulatory approvals for APIs, supporting global health solutions, with 80% of submissions approved within 6 months (industry trends).
- Skill Development: Gain expertise in CDSCO processes, WHO-GMP, and NDA/SND, rated 3.5/5 for learning (AmbitionBox).
- Stable Employer: Symbio’s 15-year legacy, 100+ employees, and Ascent Capital funding (2022) ensure growth, though appraisals lag (2.9/5).
- Competitive Pay: ₹4–7 Lakhs per annum with potential bonuses (AmbitionBox).
How to Apply
- Prepare Documents: Update CV, highlighting 2–3 years in CDSCO/DCD, WHO-GMP, or COPP; include portfolio (e.g., sample dossiers, SOPs, deficiency responses), certificates, payslip, ID proof.
- Submit Application: Email to careers@symbiogenerics.com, subject: “Regulatory Affairs Executive – Bangalore.”
- Include Details: Specify experience, current/expected CTC, notice period.
- Interview Prep: Study D&C Act, CDSCO guidelines, WHO-GMP, and COPP processes. Be ready to discuss deficiency responses or Form-10 compilation. Address post-resignation concerns (e.g., settlements) diplomatically, as 35% report delays (AmbitionBox).
- Research Symbio: Visit www.symbiogenerics.com for API focus and regulatory standards.
Why Bangalore, Karnataka?
Bangalore, India’s pharma hub, hosts Symbio’s Jigani R&D and VPL Chemicals facility, part of Karnataka’s $4 billion pharma sector (12% CAGR, Invest India). HSR Layout offers urban amenities and 150+ regulatory jobs (LinkedIn), but living costs are high (AmbitionBox). Accessible via NH-44, it’s ideal for regulatory careers.
Contact Information
- Email: careers@symbiogenerics.com
- Phone: +91-80-4121-8300
- Address: Symbio House, No. 1215, 24th Main, 11th Cross, 1st Sector, HSR Layout, Bangalore, Karnataka 560102
- Website: www.symbiogenerics.com
- LinkedIn: Symbio Generrics India Pvt. Ltd.
Join Symbio Generrics by May 20, 2025, to drive regulatory excellence in API manufacturing in Bangalore. Apply now to shape global healthcare!