
Global Regulatory Affairs Specialist
2 days ago
Job Description:
We are looking for a highly detail-oriented individual with excellent analytical skills to prepare variation documents, evaluate post-approval changes in compliance with global regulatory requirements, contribute to lifecycle management activities, and provide regulatory strategies for post-approval changes.
Responsibilities:
- Prepare Variation documents and/or evaluate post-approval CMC changes in compliance with global regulatory requirements.
- Contribute to Lifecycle Management (LCM) activities by helping to compile and review CTD dossier modules.
- Compile initial dossiers (Modules 2 & 3) for US / EU / SA / WHO / ANZ / Other Countries.
- Provide regulatory strategies and conduct evaluations of post-approval CMC changes considering ICH and country-specific guidelines.
- Manage compilation and submission of variations/supplements for US/EU/SA/WHO/ANZ/Other countries.
Requirements:
- 3+ years of experience in managing Initial submissions, Variations, and full LCM deliverables for global markets.
- Must have experience with Veeva Vault RIM.
- Proficient in ICH guidelines and regulatory guidelines for US/EU/SA/WHO/ANZ/Other countries.
- Review of technical documents from manufacturing sites like Specifications, Batch Manufacturing Records, Validations, Batch analysis data, Stability etc. required for compilation of dossier sections/Variations.
- Hands on experience in initial dossier compilation for US/EU/SA/WHO/ANZ/Other countries (Module 2 & 3).
- Experience in providing Regulatory strategies/Evaluation by performing assessment of post approval CMC Changes considering global regulatory requirements.
- Compilation and submission of Variations/supplements for US/EU/SA/WHO/ANZ/Other countries as per applicable regulatory guidelines.
About Us:
We are a dynamic team committed to delivering high-quality solutions. If you have a passion for regulatory affairs and a drive to succeed, we encourage you to apply for this exciting opportunity.
-
Regulatory Affairs Specialist
45 minutes ago
Aurangabad, Maharashtra, India beBeeRegulatory Full time ₹ 8,00,000 - ₹ 12,00,000Regulatory Affairs SpecialistThe Regulatory Affairs Specialist plays a pivotal role in ensuring compliance with international guidelines and country-specific regulations.Key Responsibilities:Prepare, review, and maintain regulatory documents to guarantee adherence.Coordinate with internal teams and external stakeholders to support product registrations and...
-
Global Food Regulatory Expert
6 days ago
Aurangabad, Maharashtra, India beBeeRegulatory Full time ₹ 2,00,00,000 - ₹ 2,50,00,000Job Description: We are seeking an experienced Regulatory Specialist to join our team. The successful candidate will have a strong understanding of international food regulations and be able to lead regulatory intelligence on domestic and export food labelling regulations. Key Responsibilities include leading regulatory intelligence, monitoring, analysing...
-
Regulatory Compliance Manager
1 week ago
Aurangabad, Maharashtra, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 30,00,000Senior Regulatory Affairs SpecialistThis role requires a Senior Regulatory Affairs Specialist to lead and manage CMC regulatory activities, including USFDA submissions, Annual Reports, and process validation documents.Responsibilities include leading CMC regulatory activities for USFDA submissions, overseeing compilation and submission of Annual Reports,...
-
Lead Regulatory Affairs Manager
4 hours ago
Aurangabad, Maharashtra, India beBeeRegulatoryAffairs Full time ₹ 12,00,000 - ₹ 25,00,000Lead Regulatory Affairs ManagerWe are seeking a highly skilled and motivated Lead Regulatory Affairs Manager to lead and manage activities in the Food Regulatory Affairs department. This role involves driving policy initiatives, liaising with government departments, engaging with industry stakeholders, generating revenue, and organizing impactful...
-
Senior Regulatory Affairs Professional
7 days ago
Aurangabad, Maharashtra, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 20,00,000Legal Manager Role OverviewThe Legal Manager is a key professional position responsible for leading our legal efforts in Gurugram. This role involves strategic leadership and management of various legal tasks, ensuring compliance with regulatory affairs and drafting high-quality legal documents.
-
Regulatory Compliance Specialist
1 week ago
Aurangabad, Maharashtra, India beBeeCompliance Full time ₹ 11,52,800 - ₹ 23,15,600Regulatory Affairs Expert SoughtWe are looking for an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance.The role involves preparing, reviewing, and submitting regulatory documentation to global health authorities, ensuring compliance with applicable regulations (FDA, EMA, CDSCO, MHRA,...
-
Aurangabad, Maharashtra, India beBeeRegulatory Full time ₹ 20,00,000 - ₹ 25,00,000Quality Assurance and Regulatory Affairs Executive.Job DescriptionThe position of Quality Assurance and Regulatory Affairs Executive is critical to ensuring compliance with regulatory requirements in the Medical Device Industry. The successful candidate will be responsible for leading a team in implementing quality systems, regulatory frameworks, and...
-
Regulatory Compliance Specialist
2 weeks ago
Aurangabad, Maharashtra, India beBeeCompliance Full time ₹ 15,00,000 - ₹ 25,00,000Job SummaryWe are seeking a seasoned Regulatory Compliance Specialist to lead our team in managing complex regulatory affairs for US FDA submissions, including ANDA preparation, review, and filing.About the RoleThe ideal candidate will have hands-on experience in Regulatory Affairs – CMC with US FDA filings, especially ANDAs. They will oversee the...
-
Compliance Specialist
6 days ago
Aurangabad, Maharashtra, India beBeePharmacovigilance Full time ₹ 1,00,00,000 - ₹ 1,50,00,000Job Overview:We are seeking a skilled professional to manage and maintain our Pharmacovigilance system.The ideal candidate will have in-depth knowledge of national/regional regulatory legislation and guidelines, as well as experience in pharmacovigilance regulations of all countries.Key Responsibilities:Organize, manage and maintain a highly compliant...
-
Global Regulatory Specialist
1 day ago
Aurangabad, Maharashtra, India beBeeRegulatory Full time ₹ 1,23,40,000 - ₹ 2,53,10,000Overview of Regulatory Oversight RoleWe are seeking a highly skilled professional to manage and coordinate regulatory examinations, oversee regulatory issues, produce reporting metrics, support training, lead technology initiatives, and maintain trackers.About the Role:Manage and coordinate regulatory examinations (logging info requests, preparing decks,...