APCER Life Sciences is a leading regulatory and compliance solutions provider in the pharmaceutical, biotechnology, and healthcare industries. We specialize in regulatory submissions, clinical research, and quality assurance, helping companies navigate complex global compliance requirements.
Our platform, PharmaBharat.com, is a trusted resource for pharma jobs, industry news, and regulatory updates, connecting professionals with top opportunities in the life sciences sector.
Job Description: Submission Specialist
We are seeking an experienced Submission Specialist to manage regulatory filings, documentation, and compliance processes for global submissions (USFDA, EMA, CDSCO, etc.).
Key Responsibilities:
✔ Prepare, review, and submit regulatory dossiers (eCTD, CTD, NDA, ANDA).
✔ Ensure compliance with ICH, GMP, and regional regulatory guidelines.
✔ Coordinate with cross-functional teams (RA, QA, Clinical) for timely submissions.
✔ Maintain tracking systems for submission deadlines and approvals.
✔ Review and update SOPs related to regulatory filings.
Qualifications & Skills:
✅ Bachelor’s/Master’s in Pharmacy, Life Sciences, or related field.
✅ 5+ years in regulatory affairs/submissions (Pharma/CRO/Healthcare).
✅ Strong knowledge of eCTD, CDISC, and regulatory databases.
✅ Excellent communication & project management skills.
How to Apply?
Interested candidates can email their updated resume to vishal.gaur@apcerls.com with the subject line:
“Application for Submission Specialist – [Your Name]”.
Join our team and contribute to shaping the future of regulatory compliance in the pharma industry!
