Regulatory Affairs Executive

3 weeks ago

Ahmedabad, Gujarat, India Lifelancer Full time

Job Title: Regulatory Affairs Executive

Job Location: Ahmedabad, Gujarat, India

Job Location Type: On-site

Job Contract Type: Full-time

Job Seniority Level: Mid-Senior level

Skills:
ROW Market, FDA Guidelines, technical documents, Review skills, Analytic Skills, Dossier Preparation,

Company Overview

BioMatrix Healthcare Private Limited, 100% export-oriented company headquartered at Ahmedabad, Gujarat, India, was established in 2007 with a thought of Supporting Life Worldwide. The company is engaged in R&D and manufacturing of oral solids, liquids, and dry syrups. Our manufacturing facility has been accredited by WHO-GMP, successfully completed an EU-GMP audit recently and complies with ANVISA, UKMHRA, and USFDA regulations. With a significant presence in African and CIS regions, we export our products to over 30 countries. We are now planning to expand our presence in Europe, Latin America and South East Asian markets. We have over 850 product registrations with more than 400 products under registrations across Europe, CIS and African countries.

We are grateful that you are interested in working with BioMatrix Healthcare Pt. Ltd. As we are moving further, we have arranged walk-in interview as per the details given below. Kindly go through the details and confirm your availability.biomatrixhealthcare.com.

Job Overview

We are seeking a passionate and experienced Regulatory Affairs Executive to join our dynamic team at BioMatrix Healthcare. This full-time, mid-level position based in Ahmedabad requires a candidate with a strong understanding of regulatory standards and processes. The successful candidate will play a crucial role in managing the company's regulatory submissions, ensuring compliance, and facilitating product registrations to support our expansion into new markets.

Qualifications And Skills
  • Expertise in ROW Market, understanding nuances in regulatory demands across regions (Mandatory skill)
  • In-depth knowledge of FDA Guidelines to ensure compliance in documentation and submissions (Mandatory skill)
  • Proficiency in handling technical documents to facilitate accurate and timely submissions (Mandatory skill)
  • Proven ability to review regulatory documents and submissions effectively, ensuring their accuracy and compliance
  • Strong analytical skills to assess regulatory data and provide critical insights for decision-making
  • Experience in dossier preparation, organizing comprehensive documents for regulatory authorities
  • Attention to detail to meticulously handle documentation and regulatory records
  • Excellent communication skills to liaise with regulatory agencies and internal departments

Job Location

Sindhubhavan Road, Thaltej, Ahmedabad.

Roles And Responsibilities
  • Review of Dossiers and Queries.
  • Maintain the status of respective countries.
  • Review of Guidelines for First-time dossier preparation for any new country.
  • Renewal Application
  • Ensuring planning and proper organization of regulatory activities and resources within the team.
  • Independent interaction with the plant team for technical documents.


Lifelancer ( https://lifelancer.com ) is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.

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