Regulatory Professional

3 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 ability to navigate tight deadlines and many stakeholders?

We are looking for a Senior Regulatory Professional to join our Regulatory Affairs team at Novo Nordisk. If you are ready for a challenging and rewarding career, read on and apply today for a life-changing opportunity.

The Position

As a 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 from safety, medical affairs, commercial to our Novo Nordisk affiliates worldwide. As part of our department, you will be responsible for planning and driving regulatory activities and deliverables according to agreed timelines and quality. You will be accountable for specific deliverables such as submission and approval of clinical trial applications, driving and coordinating preparation of meeting packages to Health Authorities, conducting Health Authority interactions, and regulatory approvals globally. You must demonstrate subject matter expertise within regulatory science including but not limited to profound knowledge about regulatory processes and activities related to global Life Cycle Management activities. 

Furthermore, in the role you will also handle: -

Compile, review, submit pre-meeting packages for authority meetings and Handle change requests.

Submission of regulatory files, response to health authorities and maintenance of marketing authorizations worldwide.

Plan and conduct regulatory interactions with health authorities, including preparing meeting requests, packages, and taking meeting minutes.

Pharmacovigilance documentation like Drug Safety Update Reports (DSUR), Periodic Safety Update Reports (PSUR), Risk Management Plan (RMP), renewals, post approval changes.

Handle Life Cycle Management (LCM) of the product, keeping the product live- clinical file protocols and Interim study reports.

Qualifications

To be successful in this role, we are looking for a candidate with the following qualifications:

6+ years of experience in related field along with Post Graduate Degree in Life Sciences is required.

International Work experience or previous experience with working in a global setting will be preferrable.

Experience in handling life cycle management of product and clinical regulatory submissions is required.

Thorough understanding of regulatory science and requirements across various regions including EU, US, China, Japan, and others.

Experience in label development, health authority interactions, and device development.

Proficiency in regulatory intelligence and therapeutic area knowledge.

Demonstrated project management skills. Excellent communication, negotiation, and presentation skills. 

Understanding of business management and the R&D value chain in the pharmaceutical industry.

Familiarity with digital health, competitive intelligence, disease understanding, statistics, pharmacovigilance, non-clinical and clinical pharmacology.

Knowledge of patient access, real-world evidence, and proficiency in written and spoken English.

About the department

The Regulatory Affairs department at Novo Nordisk plays a crucial role in ensuring compliance and patient safety. Our team works closely with relevant authorities and stakeholders throughout the product development lifecycle. With diverse academic and professional backgrounds, our team brings valuable insights and expertise to the table. We offer excellent opportunities for professional development and career growth in a dynamic and challenging environment.

  • Regulatory Professional

    5 days 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...

  • Regulatory Professional

    5 days 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

    2 months ago

    Bengaluru, India Novo Nordisk Full time

    Regulatory 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?...

  • Regulatory Professional

    4 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Regulatory 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...

  • Regulatory Professional

    1 day ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Regulatory 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...

  • Regulatory Professional

    2 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...

  • Regulatory Professional

    4 weeks ago

    Bengaluru, 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

    3 weeks ago

    Bengaluru, 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

    5 days 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...

  • Regulatory Professional

    6 days ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Regulatory 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...

  • Regulatory Professional

    3 weeks ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Regulatory 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...

  • Senior Regulatory Professional

    2 months ago

    Bengaluru, India Novo Nordisk AS 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...

  • Senior Regulatory Professional

    6 days ago

    Bengaluru, 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...

  • Senior Regulatory Professional

    5 days 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

    3 weeks ago

    Bengaluru, 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

    5 days 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...

  • Regulatory Professional I

    2 months ago

    Bengaluru, India Novo Nordisk Full time

    **Department**:RA CMC Biotech and Rare Disease **About the department** Regulatory 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...

  • Regulatory Professional I

    2 weeks ago

    Bengaluru, India Novo Nordisk Full time

    **Department: RA CMC Diabetes** **About the department** Regulatory 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...

  • Regulatory Professional I

    2 weeks ago

    Bengaluru, India Novo Nordisk Full time

    **Department**:RA CMC Biotech and Rare Disease **About the department** Regulatory 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...

  • Senior Regulatory Professional

    5 days 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...