
Africa Pharmaceutical Regulatory Affairs Professional
1 week ago
Job Overview
We are seeking a highly skilled Regulatory Affairs Specialist to join our team. The successful candidate will play a critical role in ensuring products comply with regional regulations and maintaining market access across diverse countries.
This position requires a blend of technical expertise, communication, project management, and analytical skills to navigate the complex regulatory landscape in Africa.
About Our Role
- Preparation and submission of registration and re-registration dossiers
- Submission of original documents for notarization, chamberization, and legalization
- Arrangement for indent of samples, packing material specimen, impurities, reference standards
- Establish coordination with other departments for ensuring filings and query response
- Post approval activities: submission of variations to marketing authorizations
- Preparation of certificate of pharmaceutical product (COPP) and Form 2553
- Preparation of tender documents
- Stay up-to-date on changing regulatory requirements
Requirements
- M.Pharm/B.Pharm degree
- Experience in pharmaceutical industries in African markets
Our Offerings
- Fulfilling career opportunities
- Competitive salary and benefits package
- Opportunities for professional growth and development
Key Skills
- Strong knowledge of regulatory affairs in Africa
- Excellent communication and project management skills
- Ability to analyze complex information and make decisions
- Self-motivated and results-oriented
-
Africa Regulatory Affairs Professional
2 weeks ago
Dholka, Gujarat, India beBeeRegulatory Full time ₹ 5,00,000 - ₹ 10,00,000Africa Regulatory Specialist plays a pivotal role in ensuring products adhere to regional regulations and maintaining market access across diverse countries. This position requires a blend of technical expertise, communication, project management, and analytical skills to navigate the complex regulatory landscape.Key Responsibilities:Preparation and...
-
Africa Regulatory Compliance Specialist
2 weeks ago
Dholka, Gujarat, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000At Cadila Pharmaceuticals Ltd, we are dedicated to developing and manufacturing affordable medicines for patients around the world.About the RoleA Regulatory Affairs Executive plays a critical role in ensuring products comply with regional regulations and maintaining market access across diverse countries. This position requires a blend of technical...
-
Senior Regulatory Affairs Professional
3 days ago
Dholka, Gujarat, India beBeeRegulatoryAffairs Full time ₹ 2,00,00,000 - ₹ 2,50,00,000Job Title: Senior Regulatory Affairs ProfessionalWe are seeking a highly skilled senior-level regulatory affairs professional to provide regulatory advice to cross-functional departments and guide teams on implementation of systems for regulatory expectations and compliance.Key Responsibilities:Liaison with regulatory authorities and government bodiesProvide...
-
Regulatory Affairs Specialist
5 days ago
Dholka, Gujarat, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878Job Description:Senior Manager Regulatory AffairsHandling submissions in Sugam & NSWS PortalPreparation & Submission of New Drug applications, Subsequent New Drug ApplicationsClinical trial application - Phase I, II, III, IV (Form CT-04)BA/BE Export application (Form CT-05)Test License application (Form CT-10, Form CT-13, Form CT-14, Form CT-16,...
-
Regulatory Affairs Leader
2 weeks ago
Dholka, Gujarat, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,02,50,000Regulatory Leadership RoleAs a seasoned Senior General Manager, you will lead our regulatory affairs team, driving strategic initiatives that ensure compliance with ever-changing regulations and standards.Key Responsibilities:Liaise with government agencies to facilitate coordination between customers, consultants, and internal stakeholders.Provide expert...
-
Regulatory Compliance Specialist
3 days ago
Dholka, Gujarat, India beBeeRegulatory Full time ₹ 60,00,000 - ₹ 1,20,00,000Key responsibilities for this role include:Preparing and submitting registration and re-registration dossiers as per country requirements.Submitting various original documents for notarization, chamberization, and legalization.Coordinating with other departments to ensure timely filings and query responses.Post-approval activities, including submission of...
-
Chief Regulatory Compliance Officer
5 days ago
Dholka, Gujarat, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,50,00,000Senior Manager Regulatory AffairsThis is a senior-level position responsible for handling submissions in various portals, preparing and submitting new drug applications, clinical trial applications, and other regulatory documents. The ideal candidate should have experience in regulatory affairs, strong communication skills, and the ability to work...
-
Chief Regulatory Officer
1 week ago
Dholka, Gujarat, India beBeeRegulatory Full time ₹ 2,00,00,000 - ₹ 2,50,00,000Senior General Manager Job DescriptionWe are seeking an accomplished Senior General Manager to lead our Regulatory Affairs department. The ideal candidate will possess a strong understanding of regulatory requirements and procedures in India.Job SummaryThe successful candidate will be responsible for providing strategic regulatory guidance to...
-
Chief Innovation Officer
1 week ago
Dholka, Gujarat, India beBeeBiologics Full time ₹ 1,50,00,000 - ₹ 2,50,00,000Strategic Visionary for Biologics R&D">Our ideal candidate will be responsible for developing and executing a strategic vision and roadmap for the biologics R&D portfolio.Identify and prioritize research areas with high potential for innovation and commercial impact.Oversee the planning, execution, and completion of R&D projects, ensuring they meet...
-
Senior API Development Specialist
1 week ago
Dholka, Gujarat, India beBeeAnalytical Full time ₹ 60,00,000 - ₹ 1,00,00,000Research Associate OpportunityThe selected candidate will be responsible for developing, validating, and transferring analytical methods for Active Pharmaceutical Ingredients (APIs).Key Qualifications:Developing, validating, and transferring analytical methods for APIs.Ensuring product quality, supporting process development, and facilitating regulatory...