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Symbio Generrics India Pvt. Ltd. Hiring Regulatory Affairs Executive in Bangalore

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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

Notes:

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).

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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

CategoryDetails
EducationB.Pharm, M.Pharm
Experience2–3 years in regulatory affairs (API-focused, CDSCO/DCD, WHO-GMP, COPP)
Technical SkillsCompilation of NDA/SND, Form-10, DMF; knowledge of D&C Act, 21 CFR Part 11
Regulatory KnowledgeCDSCO, DCD, WHO-GMP, COPP, Veterinary Health Certificates, GMP approvals
Soft SkillsCommunication (written/verbal), data analysis, teamwork, time management
Preferred ExpertiseDeficiency 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).
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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.
Symbio Generrics India Pvt. Ltd. Hiring Regulatory Affairs Executive in Bangalore

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!

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