
Pharmaceutical Regulatory Specialist
19 hours ago
The role of a Pharmaceutical Regulatory Specialist is to oversee the management of pharmaceutical and biological documentation, as well as registration applications for chemical active substances and biological medicinal products.
Key Responsibilities:- Ensure compliance with regulatory schedules as per the Drugs and Cosmetics Act, India GMP, and USFDA CGMP guidelines
- Maintain Cell Therapy guidelines, USFDA guidelines, and EMA regulations
- Develop and implement process validation and manufacturing process development strategies
- Validate analytical procedures and stability data
- Extensive knowledge of pharmacology, pharmacokinetics, toxicokinetic, toxicology, genotoxicity, carcinogenicity, local tolerance, safety pharmacology studies for human pharmaceuticals, single dose toxicity, and repeated dose toxicity
- Validated analytical methods and analytical methodology expertise
- Proven experience in process validation and manufacturing process development
- Clinical trial preparation and clinical study reports development
- Efficacy and safety studies expertise
- Post-marketing experience and statutory fulfillment requirements
- Effective communication and presentation skills for meetings with regulatory agencies, CROs, national & international authorities
This role requires a highly skilled individual to manage complex regulatory documents and ensure compliance with industry standards. The ideal candidate will have excellent analytical and problem-solving skills, as well as the ability to communicate effectively with stakeholders.
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Lead Pharmaceutical Operations Specialist
6 hours ago
Pune, Maharashtra, India beBeeOperations Full time ₹ 15,00,000 - ₹ 20,00,000Lead Pharmaceutical Operations Specialist","Job Description:","As a key member of our operations team, the Lead Pharmaceutical Operations Specialist will oversee all aspects of pharmaceutical production, ensuring high-quality products meet regulatory standards. This includes developing and implementing process improvements, managing equipment maintenance,...
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Regulatory Data Management Specialist
12 hours ago
Pune, Maharashtra, India beBeeRegulatory Full time ₹ 10,00,000 - ₹ 14,00,000About UsJob Title: Regulatory Data Management SpecialistAt our company, we are looking for a skilled professional to manage and analyze regulatory data. The successful candidate will have experience in pharmaceutical or medical device industries, with a focus on regulatory affairs or quality assurance.Required Skills and Qualifications:2-4 years of...
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Regulatory Compliance Specialist
3 days ago
Pune, Maharashtra, India beBeeCompliance Full time ₹ 10,00,000 - ₹ 15,00,000Regulatory Compliance Specialist Role OverviewWe are seeking a highly skilled Regulatory Compliance Specialist to join our team. The ideal candidate will have expertise in managing pharmaceutical and biological documentation, including registration applications for chemical active substances, biological medicinal products, and data control activities.The...
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Pharmaceutical Compliance Specialist
4 days ago
Pune, Maharashtra, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 1,80,00,000Job Overview:The position of Regulatory Manager is responsible for overseeing pharmaceutical and biological documentation, registration application for chemical active substances, and data control activities. This role requires scheduling adherence to the Drugs and Cosmetics Act, India GMP, and USFDA CGMP guidelines.
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Regulatory Compliance Specialist
3 days ago
Pune, Maharashtra, India beBeeCompliance Full time ₹ 1,50,00,000 - ₹ 1,80,00,000Job SummarySchedule as per regulatory guidelines and industry standards.Maintain compliance with Cell Therapy, USFDA, and EMA regulations,Key Responsibilities:Manage documentation & registration applications for pharmaceutical and biological products.Ensure clinical trial planning and prepare study reports.Evaluate efficacy and safety data.Represent the...
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Business Developer Pharmaceutical
5 hours ago
Pune, Maharashtra, India Jobs for Humanity Full timeCompany Description Doha HealthCare Group is actively engaged in the health care sector of Qatar since its inception in 2005 The company has already set up 6 major Job Title Business Developer - Pharmaceuticals Experience Required Minimum 8 years in business development alliance management or similar roles within the pharmaceutical or biotech...
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Business Developer Pharmaceutical
5 days ago
Pune, Maharashtra, India Jobs for Humanity Full time ₹ 15,00,000 - ₹ 20,00,000 per yearCompany Description Doha HealthCare Group is actively engaged in the health care sector of Qatar since its inception in 2005. The company has already set up 6 major.. Job Description Job Title:Business Developer – Pharmaceuticals Experience Required: Minimum 8+ years in business development, alliance management, or similar roles within the...
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Regulatory Compliance Expert
2 days ago
Pune, Maharashtra, India beBeeRegulatory Full time ₹ 19,99,999 - ₹ 24,99,999Regulatory Compliance ExpertAt the forefront of pharmaceutical and medical device regulatory compliance, we seek a seasoned professional to spearhead our regulatory affairs endeavors.The ideal candidate will possess in-depth knowledge of regulatory submissions, product lifecycle management, and cross-functional collaboration. Key responsibilities include...
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Pharmaceutical Manufacturing Systems Expert
2 days ago
Pune, Maharashtra, India beBeeSoftware Full time ₹ 1,50,00,000 - ₹ 2,00,00,000Senior Pharmaceutical Software SpecialistA highly skilled and experienced Senior Pharmaceutical Software Specialist is required to design, develop and configure software systems for pharmaceutical manufacturing processes. The ideal candidate will have expertise in MES recipe design and deployment, as well as a strong understanding of SDLC and pharmaceutical...
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Healthcare Marketing Regulatory Expert
1 week ago
Pune, Maharashtra, India beBeeRegulatory Full time ₹ 80,00,000 - ₹ 1,20,00,000Job Title:The Medical Content and Review Specialist plays a crucial role in the MLR review process for healthcare marketing organizations.Manages the end-to-end MLR process for clients.Responsible for scheduling, setting agendas, and leading Review Committee meetings to ensure effective collaboration.Verifies that all covered communications are properly...