Regulatory Professional II

1 week ago

Bengaluru, Karnataka, India Novo Nordisk AS Full time

Department: 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 Regulatory Professional II" with us. "Apply now" - At Novo Nordisk, we assure you will experience the best.

About the department

RA CMC & Device Bangalore is an integral part of RA CMC & Device and comprised of +60 experienced professionals associated with key regulatory processes covering Chemistry Manufacturing Control (CMC), Medical Device Reporting (MDR) and submission of regulatory files, product registrations and life cycle management of our products. We are responsible for driving the RA CMC strategies and submission activities related to various biotech and rare disease, Diabetes & Obesity products and medical devices.

We strive to be the best in the industry, delivering safe and innovative products to the patients by strategic business partnering, proactive collaboration with health authorities and efficient operations.

Our organization is dynamic and there is focus on improving work processes both in relation to implementation of new regulations and thinking "out of the box", setting bold regulatory strategies enabling us to go above and beyond to the benefit of the business and the patients we serve. We continuously strive for scientific and operational excellence.

Our work is essential to keep bringing innovative, patient-centric, and best-in-class solutions to our patients. That calls for team spirit, collaborative minds, skilled colleagues, and a great focus on knowledge-sharing. Looking forward to being surrounded by talented, cooperative, and embracing teammates in a strong and empowering culture filled with humble people.

The Position

As Regulatory Professional II, 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 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.

Qualification

7-8 years of experience within Regulatory affairs with Graduate / Postgraduate degree in Life-Science/ Chemistry/ Pharmacy/ Medicine/ Biotechnology engineering. Experience of working both in Global & Affiliate environment will be preferred. 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.

Working At Novo Nordisk

Novo Nordisk is a leading global healthcare company with a 100-year legacy of driving change to defeat serious chronic diseases. Building on our strong legacy within diabetes, we are growing massively and expanding our commitment, reaching millions around the world and impacting more than 40 million patient lives daily. All of this has made us one of the 20 most valuable companies in the world by market cap. Our success relies on the joint potential and collaboration of our more than 63,000 employees around the world. We recognize the importance of the unique skills and perspectives our people bring to the table, and we work continuously to bring out the best in them. Working at Novo Nordisk, we're working toward something bigger than ourselves, and it's a collective effort. Join us Together, we go further. Together, we're life changing.

  • Regulatory Professional II

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk AS Full time

    Department: RA CMC Biotech and 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 for you as...

  • Regulatory Professional II

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    .Department: 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...

  • Regulatory Professional

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk AS Full time

    Department: 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...

  • Associate Regulatory Professional II

    1 week ago

    Bengaluru, Karnataka, India Lifelancer Full time

    The position As Associate Regulatory Professional II, you will play a crucial role in driving, coordinating, and actively following up on multiple tasks with challenging timelines. Your responsibilities will include: Working closely with various submission teams across the organization and all countries in Europe. Managing initial clinical trial application...

  • Regulatory Professional

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Department: 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...

  • Regulatory Professional Ii

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    About the departmentRegulatory Affairs play an important role in ensuring that all new Novo Nordisk treatments and devices are developed with compliance and the patients in mind. Liaising between relevant authorities and Novo Nordisk stakeholders, Regulatory Affairs are involved throughout all phases of product development and roll-out. Our people in...

  • Regulatory Professional Ii

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Department: RA Business Transformation, Global Regulatory AffairsJob Location: BengaluruAbout the departmentGlobal Regulatory Affairs is an exciting area involved across the full value chain. We are responsible for global regulatory strategies to obtain and maintain regulatory licenses for current and future products, responsive to the worldwide business...

  • Regulatory Affairs Manager II

    1 week ago

    Bengaluru, Karnataka, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager II (International Regulatory Affairs) Career Level - D Introduction to Role: Within International Regulatory Affairs, as Regulatory professionals, bold approaches are taken to bring crucial medicines to patients globally. The focus is on accelerating Regulatory approvals for new medicines efficiently so that no...

  • Regulatory Professional Ii

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    About the departmentInternational Operations Regulatory Affairs Bangalore in Global Regulatory Affairs Global Business Services (GBS) is a global RA hub consisting of high calibre regulatory professionals. The objective of the team is to offer core RA competencies enabling NN secure fast, high quality product approvals. The team delivers full strategic and...

  • Regulatory Affairs Manager II

    1 week ago

    Bengaluru, Karnataka, India AstraZeneca Full time

    Job Title: Regulatory Affairs Manager IICareer Level - DIntroduction to Role:Join our International Regulatory Affairs team at AstraZeneca, where we are dedicated to delivering groundbreaking medicines to patients globally as efficiently as possible. An exciting opportunity awaits for a Regulatory Affairs Manager II. This role involves overseeing planning,...

  • Associate Regulatory Professional Ii

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    **Department: Global Regulatory Affairs GBS EU Submission Hub**About the DepartmentGlobal Regulatory Affairs (GRA) in Global Business Services (GBS) Bangalore is a global RA hub consisting of high calibre regulatory professionals. The objective of the team is to offer core RA competencies enabling NN secure fast, high quality product approvals. The team...

  • Regulatory Professional

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Regulatory 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...

  • Senior Regulatory Professional

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk AS Full time

    Department: 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...

  • Senior Regulatory Professional

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk AS Full time

    Department: 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...

  • Senior Regulatory Professional

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk AS Full time

    Job Title: Senior Regulatory Professional Department : Operational Centre of Excellence (OCE) About the department Operational Centre of Excellence also known as OCE is a part of IOSO RA Bangalore, OCE was established in May 2021. The main objective of OCE is to extend their expertise to affiliates to absorb their increasing workload by taking on...

  • Senior Regulatory Professional

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    The position As a Senior Regulatory Professional, you are expected to demonstrate leadership by setting the regulatory strategy and being responsible for planning, preparing, and submitting high quality files to the health authorities achieving fast approvals. You will work as an integrated part of global cross-functional teams with stakeholders ranging...

  • Senior Regulatory Professional

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Department: 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 stakeholders?...

  • Regulatory Professional I

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Department:RA CMC Biotech and Rare DiseaseAbout 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,...

  • Senior Regulatory Professional

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk AS Full time

    Department: Labelling Operations Are you a graphic designer who would like their work to impact patient's lives? Do you thrive in a working environment where close collaboration with key stakeholders and having and innovative mindset is essential? Do you have a can-do attitude with continuous improvement as one of your career objectives? Then we might...

  • Regulatory Professional I

    1 week ago

    Bengaluru, Karnataka, India Novo Nordisk AS Full time

    Department: Regulatory Affairs CMC & Device 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...