Regulatory Professional
5 days ago
: RA CMC Diabetes & ObesityAre you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you as “CMC Regulatory Professional II” with us. "Apply now" - At Novo Nordisk, we assure you will experience the best.About the departmentRegulatory Affairs plays an important role in ensuring all Novo Nordisk Medicines and Devices developed with compliance and keeping patients in mind. Liaising between relevant authorities and Novo Nordisk stakeholders, Regulatory Affairs will be involved throughout phases of product development, NDA and maintenance of LCM activities. Our people in Regulatory Affairs come from diverse academic and professional backgrounds, bringing valuable insights and expertise to the team and the company to ensure minimum time to reach the markets. This makes Regulatory Affairs a truly multi-disciplinary place to work with high professional standards, excellent opportunities for fast-paced professional development and career opportunities.The PositionAs Regulatory Professional, the candidate will be responsible for making the timely submissions to the Health Authorities worldwide. The candidate is expected to establish and maintain the CMC part of the core regulatory file. Further responsibilities include Life Cycle Management.Support submission planning: Apply intelligence and negotiation skills to develop Regulatory strategy. Create and maintain Regulatory Submission Plan including creation/review documents.Support submission of Regulatory files, Handling Change Requests & Deviations, response to RSI/ HA query worldwide, Annual Reporting and maintenance of marketing authorization globally.Support to NDA, Renewals & Post Approval Changes.Hands on experience with Veeva Vault (Submission & Registrations).The candidate will be playing a key role in stakeholder management and will be responsible for ensuring appropriate use of communication channels to strengthen relationships with the stakeholders.Qualification6+ years of experience within Regulatory affairs/CMC with Graduate / Postgraduate degree in Life-Science/ Chemistry/ Pharmacy/ Medicine/ Biotechnology engineering.Experience of working both in Global & Affiliate environment .Good understanding of end-to-end Regulatory Processes and Life Cycle Management.Bold and strong personality with proven negotiation skills and excellent project management skills.Should be able to convince and put forward the facts confidently.Highly proactive and able to take initiatives & manage multiple priorities. Self-managed, strong personal drive and ability to engage with colleagues and peers towards delivering excellent performance and results.High cultural sensitivity and comfortable working with different countries and cultures across multiple time-zones.Excellent written/spoken communication skills.
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Regulatory Professional
7 days ago
Bengaluru, India Novo Nordisk AS Full timeDepartment : RA CMC Diabetes & Obesity Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you as “CMC...
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Regulatory Professional
4 weeks ago
Bengaluru, India Novo Nordisk AS Full time. Department: Regulatory Affairs Rare Blood Disorders Job Level: 6 Are you passionate about driving regulatory strategy and life cycle management of product portfolio ensuring interactions with regulatory authorities across the globe? Do you thrive in a multi-disciplinary environment requiring a unique combination of scientific insights and...
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Regulatory Professional
2 weeks ago
Bengaluru, Karnataka, India Novo Nordisk AS Full timeDepartment: RA CMC Diabetes & ObesityAre you passionate about your work? Do you strive for process excellence in the most efficient way? Are you a change-maker with an innovative mindset, eager to shape the future? If you excel in what you do, then this role as a CMC Regulatory Professional II is an amazing opportunity for you at Novo Nordisk. Join us for a...
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Regulatory Professional
2 days ago
Bengaluru, India Novo Nordisk Full timeDepartment : RA CMC Diabetes & ObesityAre you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you as “CMC...
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Regulatory Professional
2 weeks ago
Bengaluru, Karnataka, India Novo Nordisk Full timeDepartment: RA CMC Diabetes & Obesity Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you as "CMC...
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Regulatory Professional
1 week ago
Bengaluru, India Novo Nordisk Full timeRegulatory Professional **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department: Global Regulatory Affairs** - Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment?...
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Regulatory Professional
2 weeks ago
Bengaluru, Karnataka, India Novo Nordisk Full timeRegulatory Professional **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department: Research & Development** - Do you want to play a key role in accelerating the development of our patient-focused products? Are you passionate about regulatory science and executing on regulatory strategies to bring innovative...
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Regulatory Professional
4 weeks ago
Bengaluru, India Novo Nordisk Full time**Department**:RA GLP-1 **Position** As a Regulatory Professional you are expected to handle below responsibilities: - Become a member of cross functional project teams including study groups and submission teams and provide regulatory input within the Semaglutide department. - Drive, coordinate and actively follow-up on several tasks with challenging and...
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Regulatory Professional
1 month ago
Bengaluru, India Novo Nordisk Full timeDepartment: RA CMC Diabetes & Obesity Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you as “CMC...
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Regulatory Professional
4 weeks ago
Bengaluru, India Novo Nordisk Full timeDepartment: RA CMC Diabetes & Obesity Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you as “CMC...
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Regulatory Professional
4 days ago
Bengaluru, India Novo Nordisk Full timeDepartment: RA CMC Diabetes & Obesity Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for you as “CMC...
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Regulatory Professional
7 days ago
Bengaluru, India Novo Nordisk Full time.Department: Regulatory Affairs Rare Blood Disorders Are you passionate about driving regulatory strategy and life cycle management of product portfolio ensuring interactions with regulatory authorities across the globe? Do you thrive in a multi-disciplinary environment requiring a unique combination of scientific insights and ability to navigate tight...
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Regulatory Professional
2 weeks ago
Bengaluru, Karnataka, India Novo Nordisk Full timeRegulatory ProfessionalCategory:Reg Affairs & Safety PharmacovigilanceLocation:Bangalore, Karnataka, INDepartment:RA CMC & DeviceAbout the Department RA CMC & Device Bangalore in Global Business Services (GBS) Bangalore is a part of Bangalore Global Development hub consisting of high calibre regulatory professionals. The objective of the team is to offer...
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Regulatory Professional
2 weeks ago
Bengaluru, Karnataka, India Novo Nordisk Full timeRegulatory Professional **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department**:RA CMC & Device**About the Department** - RA CMC & Device Bangalore in Global Business Services (GBS) Bangalore is a part of Bangalore Global Development hub consisting of high calibre regulatory professionals. The objective of the...
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Regulatory Professional
4 weeks ago
Bengaluru, Karnataka, India Novo Nordisk Full timeRegulatory Professional **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department: RA Submission Systems Development**The position** - As a Regulatory Professional at Novo Nordisk, you will be responsible for a variety of tasks and responsibilities, including:- Providing support, maintenance, and gatekeeping and...
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Senior Regulatory Professional
1 week ago
Bengaluru, India Novo Nordisk AS Full timeDepartment: Regulatory Affairs CMC Biotech & Rare DiseaseAre you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting for...
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Senior Regulatory Professional
2 weeks ago
Bengaluru, Karnataka, India Novo Nordisk AS Full timeDepartment: Regulatory Affairs CMC Biotech & Rare Disease Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity waiting...
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Senior Regulatory Professional
2 weeks ago
Bengaluru, India Novo Nordisk AS Full timeDepartment: Regulatory Affairs CMC Biotech & Rare Disease Are you passionate about what you are doing? Do you want to build excellence within processes in the most efficient way? Do you have an innovative mindset to drive change in a future-ready environment? Are you best at what you do? If so, raise your hand as there is an exciting opportunity...
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Senior Regulatory Professional
2 weeks ago
Bengaluru, Karnataka, India Novo Nordisk AS Full timeDepartment: RA Diabetes Are you passionate about driving regulatory strategy and life cycle management of product portfolio ensuring interactions with regulatory authorities across the globe? Do you thrive in a multi-disciplinary environment requiring a unique combination of scientific insights and ability to navigate tight deadlines and many...
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Senior Regulatory Professional
4 weeks ago
Bengaluru, India Novo Nordisk AS Full timeDepartment: RA Diabetes Are you passionate about driving regulatory strategy and life cycle management of product portfolio ensuring interactions with regulatory authorities across the globe? Do you thrive in a multi-disciplinary environment requiring a unique combination of scientific insights and ability to navigate tight deadlines and many...
