Regulatory Affairs Sr Manager
Regulatory Affairs Sr Manager
Posted on :
12-02-2025
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1 Vacancy
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Job Description
Job Title: Regulatory Affairs Sr. Manager
Job Location: Ahmedabad Gujarat India
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level: Director
Skills:
Regulatory Compliance FDA Regulations Quality Assurance Risk Management Project Management Communication Skills Team Leadership Problem Solving
Company Overview
BBioMatrix Healthcare Private Limited 100% exportoriented 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 WHOGMP successfully completed an EUGMP 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 walkin interview as per the details given below. Kindly go through the details and confirm your availability.
Job Overview
We are seeking a Regulatory Affairs Senior Manager at our Ahmedabad location. This is a fulltime 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 Skills
B.pharm / M.pharm
Sindhubhavan Road Thaltej Ahmedabad
Roles And Responsibilities
Regulatory Compliance FDA Regulations Quality Assurance Risk Management Project Management Communication Skills Team Leadership Problem Solving
Company Overview
BBioMatrix Healthcare Private Limited 100% exportoriented 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 WHOGMP successfully completed an EUGMP 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 walkin interview as per the details given below. Kindly go through the details and confirm your availability.
Job Overview
We are seeking a Regulatory Affairs Senior Manager at our Ahmedabad location. This is a fulltime 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 Skills
B.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.
Sindhubhavan Road Thaltej Ahmedabad
Roles And Responsibilities
- Overall responsibility for managing regulatory submissions for respecting Zone query responding and product lifecycle maintenance for the companys portfolio.
- Leading a team of regulatory professionals.
- To plan prepare and review of highquality eCTD dossier with support and guidance assuring technical congruency and regulatory compliance meeting agreedupon timelines.
- Renewal Application
- Ensuring planning and proper organization of regulatory activities and resources within the team.
- Independent interaction with the companys overseas client for regulatoryrelated matters.
- Established a system of recording technical comments from various regulatory teams on change control imitated by R&D or manufacturing plant.
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Employment Type
Full Time
Key Skills
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