[Immediate Start] Regulatory Affairs Sr. Manager

3 days ago

Vadodara, India Lifelancer Full time

Job Title Regulatory Affairs Sr ManagerJob Location Ahmedabad Gujarat IndiaJob Location Type On-siteJob Contract Type Full-timeJob Seniority Level DirectorSkills Regulatory Compliance FDA Regulations Quality Assurance Risk Management Project Management Communication Skills Team Leadership Problem Solving Company OverviewBBioMatrix 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 Job OverviewWe are seeking a Regulatory Affairs Senior Manager at our Ahmedabad location This is a full-time position requiring a minimum of 7 years of work experience The candidate will be responsible for ensuring compliance with drug regulations leading the regulatory affairs team and supporting our expansion into new markets Qualifications And SkillsB pharm M pharm Regulatory Compliance Mandatory skill Expertise in maintaining compliance with local and international drug regulatory authorities FDA Regulations Mandatory skill Thorough understanding and experience with FDA regulatory procedures and policies Job LocationSindhubhavan Road Thaltej AhmedabadRoles And Responsibilities Overall responsibility for managing regulatory submissions for respecting Zone query responding and product life-cycle maintenance for the companys portfolio Leading a team of regulatory professionals To plan prepare and review of high-quality eCTD dossier with support and guidance assuring technical congruency and regulatory compliance meeting agreed-upon timelines Renewal Application Ensuring planning and proper organization of regulatory activities and resources within the team Independent interaction with the companys overseas client for regulatory-related matters Established a system of recording technical comments from various regulatory teams on change control imitated by R D or manufacturing plant 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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