Manager Global Regulatory Affairs
2 months ago
Assistant Manager
Global Regulatory Affairs
Bangalore, India
Job Description:
- Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products for emerging markets.
- Biosimilars or injectables experience is mandatory for this role .
Responsible for :
- Development and Implementation of regulatory strategies for global registrations for products within the biosimilars portfolio
- Coordination of activities and deliverables provided by other cross-functional teams to support the development, approval, and long-term planning of biosimilar products
- Collaboration with partners to develop and execute global regulatory activities
Key Activities :
Regulatory Strategy and Execution
- Plan and manage development of high quality regulatory documents, including briefing documents, CTAs, IND / IMPD, MAA / BLA, and responses to questions for products in compliance with approved filing plans, timelines, and regulatory requirements
- Provide regulatory direction on global regulatory requirements to support product development
- Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout product development and life cycle
- Support development and execution of clinical/non-clinical strategies
- Provide review, input, and regulatory advice into study concept CMC documents, protocols and reports used to support product development and registration
- Collaborate with partners affiliates as required to ensure effective implementation of approved global regulatory strategies and plans
- With minimal supervision, participate in development of risk management and contingency planning
- Ensure and lead regulatory compliance for biosimilar products
- Participation in regulatory meetings with Health Authorities
-
Global Regulatory Affairs Expert
2 weeks ago
Bengaluru, Karnataka, India Inter IKEA Group Full timeWe are looking for a Global Regulatory Affairs Expert to lead our regulatory development and compliance efforts in India. As a key member of our team, you will be responsible for aligning public affairs and regulatory priorities, communicating with stakeholders, and leading strategic initiatives related to regulatory affairs.The ideal candidate will have at...
-
Manager Global Regulatory Affairs
1 month ago
Bengaluru, India Biocon Biologics Full timeAssistant ManagerGlobal Regulatory AffairsBangalore, IndiaJob Description:- Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products for emerging markets.- Biosimilars or injectables experience is mandatory for this role.Responsible for:- Development and Implementation of...
-
Manager Global Regulatory Affairs
1 month ago
Bengaluru, India Biocon Biologics Full timeRegulatory Affairs ManagerBangalore, IndiaJob Description:Hands on experience on drug substance manufacturing process, designing and executing process characterization studies (upstream, downstream, formulation) as well as process comparability for biologics (monoclonal antibodies/growth factors/hormones)Accountable for development and execution of CMC...
-
Manager Global Regulatory Affairs
2 months ago
Bengaluru, India Biocon Biologics Full timeAssistant ManagerGlobal Regulatory AffairsBangalore, IndiaJob Description:Accountable for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products for emerging markets.Biosimilars or injectables experience is mandatory for this role.Responsible for:Development and Implementation of...
-
Manager Global Regulatory Affairs
1 month ago
Bengaluru, India Biocon Biologics Full timeRegulatory Affairs ManagerBangalore, IndiaJob Description:- Hands on experience on drug substance manufacturing process, designing and executing process characterization studies (upstream, downstream, formulation) as well as process comparability for biologics (monoclonal antibodies/growth factors/hormones)- Accountable for development and execution of CMC...
-
Manager Global Regulatory Affairs
2 months ago
Bengaluru, India Biocon Biologics Full timeRegulatory Affairs ManagerBangalore, IndiaJob Description:Hands on experience on drug substance manufacturing process, designing and executing process characterization studies (upstream, downstream, formulation) as well as process comparability for biologics (monoclonal antibodies/growth factors/hormones)Accountable for development and execution of CMC...
-
Manager Global Regulatory Affairs
2 months ago
Bengaluru, India Biocon Biologics Full timeRegulatory Affairs ManagerBangalore, IndiaJob Description:Hands on experience on drug substance manufacturing process, designing and executing process characterization studies (upstream, downstream, formulation) as well as process comparability for biologics (monoclonal antibodies/growth factors/hormones)Accountable for development and execution of CMC...
-
Manager Global Regulatory Affairs
2 months ago
Bengaluru, India Biocon Biologics Full timeRegulatory Affairs Manager Bangalore, India Job Description: Hands on experience on drug substance manufacturing process, designing and executing process characterization studies (upstream, downstream, formulation) as well as process comparability for biologics (monoclonal antibodies/growth factors/hormones) Accountable for development and execution of CMC...
-
Regulatory Affairs Manager
4 weeks ago
Bengaluru, India Philips Full timeJOB DESCRIPTION Job Title Regulatory Affairs Manager Job Description Job Title : Regulatory Affairs Manager Position Summary: You are part of Philips Patient Care Informatics (PCI) Regulatory Affairs Organization. The Regulatory Affairs team comprises a group of enthusiastic professionals across the globe that work as a cohesive team to...
-
Regulatory Affairs
3 weeks ago
Bengaluru / Bangalore, Chennai, India Ajay Bhardwaj (Proprietor Of Ocean Biomed) Full timeSummary:The Regulatory Affairs Officer ensures that pharmaceutical products comply with industry regulations. This role involves preparing and submitting regulatory documents, managing compliance, and maintaining product approvals.Roles and Responsibilities:Regulatory Submissions: Prepare and submit regulatory documents for product approvals and...
-
Regulatory Affairs Director
4 weeks ago
Bengaluru, Karnataka, India Parexel Full timeDirector of Regulatory Affairs and Clinical TrialsWe are seeking a highly experienced Director to lead our regulatory affairs and clinical trials team.About the RoleThis is a senior leadership position that will oversee the strategic direction of our regulatory affairs and clinical trials operations.Key ResponsibilitiesProvide strategic guidance on...
-
Regulatory Affairs Manager
4 weeks ago
Bengaluru, Karnataka, India Lifelancer Full timeAt Lifelancer, we are seeking a highly skilled Regulatory Affairs Manager to join our team in Electronic City Phase 1 - Bangalore. This is a Specialist level position that will play a critical role in supporting the license security and product compliance on global markets.The successful candidate will have a minimum of 5 years of experience in a Pharma...
-
Regulatory Affairs IT Project Manager
1 week ago
Bengaluru, Karnataka, India Biocon Biologics Full timeIT Project Manager Regulatory Affairs - Biocon BiologicsWe are seeking an experienced IT Project Manager to join our Regulatory Affairs team at Biocon Biologics.The successful candidate will lead key technology and digital projects, ensuring successful rollouts and effective collaboration with cross-functional teams. With a strong background in project...
-
Regulatory Affairs Specialist
4 weeks ago
Bengaluru, Karnataka, India Lifelancer Full timeCompany OverviewLifelancer is a leading talent-hiring platform in the Life Sciences, Pharma, and IT sectors. Our mission is to connect top talent with opportunities in these fields. Job Title: Regulatory Affairs ManagerSalary: $120,000 - $180,000 per yearLocation: Remote or On-Site (Flexible)Job Description:We are seeking an experienced Regulatory Affairs...
-
Regulatory Affairs Leader for Medical Devices
2 weeks ago
Bengaluru, Karnataka, India Philips Full timeJob Title Principal Regulatory Affairs Specialist About the RoleWe are seeking a seasoned Regulatory Affairs professional to lead our efforts in ensuring compliance with global regulations and standards for medical devices. As a key member of our team, you will be responsible for developing and executing regulatory strategies for new product development,...
-
Regulatory Affairs Associate
6 months ago
Bengaluru, India Parexel Full time**Regulatory Affairs Associate** 2 to 5 years of experience in Regulatory Affairs-CMC, should be willing to work in EU Shifts. - To provide regulatory input on procedural and CMC documentation requirements specific to as defined by Health Authorities for assigned deliverable(s) including: - Submission delivery strategy - Review of documents - Analysis of...
-
Regulatory Affairs Specialist
2 weeks ago
Bengaluru, Karnataka, India ScaleneWorks Full timeJob Description Overview:ScaleneWorks seeks a skilled Regulatory Affairs Specialist to lead our regulatory efforts. As a key member of the team, you will be responsible for ensuring the compliance of our products with relevant regulations.About the Role:This is an exciting opportunity to join ScaleneWorks as a Regulatory Affairs Specialist. You will be...
-
Regulatory Affairs Professional
3 weeks ago
Bengaluru, Karnataka, India Lifelancer Full time**Job Title:** Regulatory Affairs ProfessionalAbout the Role:We are seeking an experienced Regulatory Affairs Professional to join our team at Apotex. As a key member of our Regulatory Affairs department, you will be responsible for preparing and submitting regulatory documents, including drug master files, amendments, and annual reports.Key...
-
Lead - Regulatory Affairs
6 months ago
Bengaluru, India Indegene Full timeTitle: Lead - Regulatory Affairs Date: May 10, 2024 Location: Bangalore, KA, IN We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that’s bold, industrious and nimble. With Indegene, you gain a...
-
Bengaluru, Karnataka, India Philips Full timeJob DescriptionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Philips.This is a challenging role that requires a deep understanding of regulatory compliance and a passion for shaping the future of healthcare technology.About the RoleThe successful candidate will be responsible for developing and implementing global regulatory...