
Regulatory Affairs Professional
4 days ago
This role is responsible for leading the development and execution of regulatory strategies and documents in support of clinical trials and product registration.
- Key Responsibilities:
Develop and implement regulatory strategies to ensure compliance with relevant regulations and guidelines.
Prepare and review regulatory documents, including clinical trial protocols, informed consent forms, and regulatory submissions.
Collaborate with cross-functional teams, including clinical operations, medical writing, and regulatory affairs, to ensure timely and accurate delivery of regulatory documents.
Maintain knowledge of regulatory requirements and guidelines, including ICH, GCP, and FDA regulations.
Provide regulatory guidance and support to colleagues and external partners as needed.
- Bachelor's degree in a scientific or health-related field
- Proven experience in regulatory affairs, including clinical trial management and document preparation
- Strong understanding of regulatory requirements and guidelines
- Excellent communication and project management skills
- Ability to work effectively in a team environment
- Ongoing training and professional development opportunities
- Collaborative and dynamic work environment
- Competitive compensation and benefits package
- Maintenance of current knowledge of regulatory requirements and guidelines
- Ability to adapt to changing priorities and deadlines
-
Regulatory Affairs Professional
4 days ago
Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 8,46,992 - ₹ 12,99,898Regulatory Affairs AssociateThis is a critical role that involves providing regulatory support to various departments across the organization. The successful candidate will be responsible for ensuring that all regulatory activities align with business needs.Key Responsibilities:The Regulatory Affairs Associate will be responsible for:Providing regulatory...
-
Regulatory Affairs Specialist
20 hours ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 90,00,000 - ₹ 1,20,00,000Regulatory Affairs SpecialistThis role is a great opportunity for individuals with a strong understanding of regulatory affairs and a passion for ensuring compliance. The Regulatory Affairs Specialist will play a critical role in assisting international regulatory teams with navigating evolving business needs in the Indian market.Key...
-
Regulatory Affairs Specialist
4 days ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 15,00,000 - ₹ 25,00,000Job Title: Regulatory Affairs Specialist">Job Description:">We are seeking a highly motivated and detail-oriented Regulatory Affairs Specialist to manage and support regulatory submissions, ensure compliance with global regulatory requirements, and maintain the highest standards of operational excellence in regulatory processes.">Technical skills: Deep...
-
Regulatory Affairs Specialist
4 days ago
Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 80,00,000 - ₹ 2,00,00,000Regulatory Affairs Specialist JobThis is a critical role in our organization, responsible for managing and supporting regulatory submissions to ensure compliance with global regulations.The ideal candidate will have a deep understanding of CDSCO regulations, including the Drugs and Cosmetics Act, 1940, and related rules, guidelines, and circulars.Key...
-
Regulatory Affairs Specialist
2 days ago
Bengaluru, Karnataka, India Biocon Biologics Full timePosition SummaryThe Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings and variations in...
-
Regulatory Affairs Specialist
3 days ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,00,00,000 - ₹ 1,50,00,000This role plays a pivotal part in bringing medical devices to market while ensuring ongoing compliance. Key responsibilities include participating on cross-functional teams, developing global regulatory strategies, authoring regulatory submissions, and interacting with regulatory agencies.The ideal candidate will have expertise in product development...
-
Senior Regulatory Affairs Specialist
2 days ago
Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full timeRegulatory Affairs ManagerWe are seeking an experienced Regulatory Affairs Manager to oversee and execute all regulatory activities for drug substances and products.
-
Regulatory Affair Manager
3 weeks ago
Bengaluru, Karnataka, India Natural Biogenex Pvt Ltd Full timeNote: The selected candidate must be willing to visit the manufacturing facility in Vasanthanarsapura, Tumkur at least two days a week and/or as required based on operational and regulatory needs.Job Title: Regulatory Affairs ManagerLocation: Jayanagar 2nd block, Bengaluru/Vasanthnarasapura KIADB Industrial Area, Tumkur, KarnatakaExperience: 12 - 15 years...
-
Regulatory Affairs Specialist
18 hours ago
Bengaluru, Karnataka, India beBeeRegulatory Full time ₹ 1,50,00,000 - ₹ 2,00,00,000Job Title: Regulatory Affairs SpecialistWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. The ideal candidate will have expertise in regulatory management and a strong understanding of medical device regulations.About the Role:This is an exciting opportunity for a talented professional to work with our international regulatory...
-
Regulatory Affairs Specialist
17 hours ago
Bengaluru, Karnataka, India beBeeRegulatoryAffairs Full time ₹ 9,00,000 - ₹ 12,00,000Job OpportunityWe are seeking a highly skilled Regulatory Affairs Professional to support our organization in Bengaluru, India. As a key team member, you will play a crucial role in ensuring compliance with regulatory requirements and providing expertise throughout the submission lifecycle.Main Responsibilities:Collaborate with cross-functional teams to...