Regulatory Affairs Executive 15h Left

4 weeks ago

Ahmedabad, Gujarat, India Lifelancer Full time

Job Title Regulatory Affairs ExecutiveJob Location Ahmedabad Gujarat IndiaJob Location Type On-siteJob Contract Type Full-timeJob Seniority Level Mid-Senior levelSkills ROW Market FDA Guidelines technical documents Review skills Analytic Skills Dossier Preparation Company OverviewBioMatrix 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 OverviewWe 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 LocationSindhubhavan 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 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 For more details and to find similar roles please check out the below Lifelancer link

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