16 Oct
|
AURASOUL LIFESCIENCE
|
Vadodara
16 Oct
AURASOUL LIFESCIENCE
Vadodara
Job Title: Executive – Regulatory Affairs & Quality Compliance
Company Name: AURASOUL LIFESCIENCE LLP
Location: Vadodara, Gujarat
Job Type: Full-Time, Permanent
Department: Regulatory Affairs & Quality Compliance
Experience: 1–3 Years Preferred (Freshers with relevant knowledge may also apply)
Working Days: Monday to Saturday (5th Saturday off)
Working Hours: 9:00 AM to 6:00 PM
About AURASOUL LIFESCIENCE LLP
AURASOUL LIFESCIENCE LLP is a growing pharmaceutical and nutraceutical company specializing in manufacturing, contract manufacturing, private labeling, and exports. We are committed to quality, regulatory compliance, innovation, and expanding our presence in international markets.
We are looking for a motivated and detail-oriented professional to join our Regulatory Affairs & Quality Compliance team and contribute to pharmaceutical registration projects and international market expansion.
Job Summary The candidate will be responsible for regulatory dossier preparation, registration project coordination, regulatory query management, packaging development review, and evaluating regulatory requirements for new markets. The role requires coordination with cross-functional teams to ensure timely completion of regulatory projects and compliance with applicable requirements.
Key Responsibilities
- Prepare and compile regulatory dossiers for new product registration projects.
- Manage and coordinate regulatory queries for products under registration.
- Review and approve packaging materials for registration and commercial products, ensuring compliance with applicable regulatory requirements.
- Conduct feasibility assessments of regulatory requirements for new international markets.
- Coordinate with internal departments for regulatory documentation and project execution.
- Work closely with cross-functional teams on new dosage forms, product development, and entry into new markets.
- Maintain regulatory documentation, project records, and registration status updates.
- Track project timelines, pending requirements,
and regulatory submissions.
- Support the regulatory team in ensuring compliance with applicable pharmaceutical regulations and quality standards.
Required Skills
- Knowledge of pharmaceutical Regulatory Affairs and product registration processes.
- Understanding of regulatory dossier preparation and documentation.
- Good written and verbal communication skills.
- Strong documentation, coordination, and organizational skills.
- Proficiency in MS Office, particularly Microsoft Word and Excel.
- Ability to manage multiple projects and meet deadlines.
- Attention to detail and a quality-focused approach.
- Ability to work collaboratively with cross-functional teams.
Educational Qualification
- B.Pharm, M.Pharm, B.Sc., M.Sc., or another relevant qualification in Pharmacy, Life Sciences, or a related field.
- Candidates with relevant Regulatory Affairs knowledge or experience in the pharmaceutical industry will be preferred.
Experience
- Preferred: 1–3 years of experience in Pharmaceutical Regulatory Affairs, Dossier Preparation, Product Registration, or Regulatory Documentation.
- Freshers with relevant academic knowledge, strong documentation skills, and a willingness to learn may also apply.
Why Join AURASOUL LIFESCIENCE LLP?
- Opportunity to work on pharmaceutical registration projects and regulatory documentation.
- Exposure to international regulatory requirements and new-market feasibility assessments.
- Opportunity to collaborate with cross-functional teams.
- Professional development in the pharmaceutical and nutraceutical industry.
- Prospect to contribute to the company's international market expansion.
How to Apply Interested candidates who meet the above requirements are invited to apply through Indeed with their updated resume.
Company: AURASOUL LIFESCIENCE LLP
Job Location: Fourth Floor, 424-B, S9 Square, Sama-Savli Road, Vadodara, Gujarat – 390008
Contact Person: Mr. Vraj Parmar ((phone hidden))
Job Title: Executive – Regulatory Affairs & Quality Compliance
Employment Type: Full-Time, Permanent
Pay: ₹15,000.00 - ₹35,000.00 per month
Work Location: In person
📌 Executive – Regulatory Affairs & Quality Compliance (Vadodara)
🏢 AURASOUL LIFESCIENCE
📍 Vadodara