Regulatory Professional I

4 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 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 Position**
- Support preparation of Regulatory file followed by Publishing and Distribution of Dossier.
- 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).

**Qualification**
- 5-7 years of experience within CMC Regulatory affairs with Graduate / Postgraduate degree in Life-Science/ Chemistry/ Pharmacy/ Medicine.
- 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.
- 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**

At Novo Nordisk we don’t wait for change, we drive it. We’re a dynamic company in an even more dynamic industry, and we know that what got us to where we are today is not necessarily what will make us successful in the future. We embrace the spirit of experimentation, striving for excellence without fixating on perfection. We never miss the opportunities to develop, we seize them. From research and development, manufacturing, marketing, and sales
- we're all working to move the needle on patient care.

**Contact**

**Deadline**

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we’re life changing.

  • Regulatory Professional I

    6 days ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Regulatory Professional I **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN- .- **Department**:RA CMC Diabetes & Obesity**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...

  • Regulatory Professional I

    1 week ago

    Bengaluru, India Novo Nordisk AS Full time

    Department: RA Submission Systems Development Are you passionate about ensuring compliance and streamlining regulatory processes in the dynamic field of life sciences? Do you have a passion for regulatory affairs and a desire to shape the future of the industry? We are looking for a Regulatory Process Expert to join the team implementing...

  • Regulatory Professional I

    1 week ago

    Bengaluru, India Novo Nordisk Full time

       Department: RA Submission Systems Development Are you passionate about ensuring compliance and streamlining regulatory processes in the dynamic field of life sciences? Do you have a passion for regulatory affairs and a desire to shape the future of the industry? We are looking for a Regulatory Process Expert to join the team implementing centralised...

  • Senior Regulatory Professional

    4 weeks 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...

  • Regulatory Professional II

    4 weeks ago

    Bengaluru, India Novo Nordisk AS Full time

    Department: Labelling Operations Are you skilled in graphic design and have experience in regulatory affairs? Are you ready for the next step in your career? We are looking for a Regulatory Professional II to join our Global Regulatory Affairs team in Novo Nordisk. If you have a passion for design and ensuring regulatory compliance, read on and apply...

  • Regulatory Professional Ii

    6 days ago

    Bengaluru, Karnataka, India Novo Nordisk Full time

    Regulatory Professional II **Category**:Reg Affairs & Safety Pharmacovigilance**Location**:Bangalore, Karnataka, IN**Department: Labelling Operations**The Position** - As a Regulatory Professional II at Novo Nordisk, you will: - Conceptualize, design, and develop outstanding creative based on written briefs. - Have an advanced understanding of design...

  • Regulatory Professional I

    2 weeks ago

    Bengaluru, India Novo Nordisk AS Full time

    Department: EU Submissions Hub Are you ready to make a difference in the lives of millions of people living with a serious chronic disease? Join Novo Nordisk, a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. We are looking for a dedicated EU Submission Lead for Clinical Trials to...

  • Regulatory Professional I

    2 weeks ago

    Bengaluru, India Novo Nordisk Full time

    The position As Regulatory Professional, 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...

  • QA Professional I

    4 weeks ago

    Bengaluru, India Cepheid Full time

    **QA Professional I** At Cepheid, we are passionate about improving health care through fast, accurate diagnostic testing. Our mission drives us, every moment of every day, as we develop scalable, groundbreaking solutions to solve the world’s most complex health challenges. Our associates are involved in every stage of molecular diagnostics, from ideation...

  • Senior Quality Professional I

    4 weeks ago

    Bengaluru, India Novo Nordisk AS Full time

    Department : SOP Service Center Are you detail-oriented and passionate about ensuring quality standards? Do you thrive in a dynamic and global team environment? We are looking for an Advanced Quality Professional I to join our Quality GBS department at Novo Nordisk. If you are ready for a challenging and rewarding career, read on and apply today for a...

  • Regulatory Associate Manager

    2 weeks ago

    Bengaluru, Karnataka, India GSK Full time

    Nazwa biura: Bengaluru Luxor North TowerPosted Date: Apr Job Purpose :Responsible for timely delivery of regulatory activities of multiple Rx and/or Vx projects across dosage forms.Represents CD on Regulatory Networks and Matrix Teams providing guidance to Pharma Supply Chain (PSC), Commercial, Quality Assurance, 3rd Party Contract Manufacturing...

  • Regulatory Professional- Ioso Ra Operations Hub

    4 weeks ago

    Bengaluru, India Novo Nordisk Full time

    **Department: International Operations Regulatory Affairs** **About the department** International 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,...

  • Regulatory Professional I

    2 weeks ago

    Bengaluru, India Novo Nordisk Full time

       Department: EU Submissions Hub Are you ready to make a difference in the lives of millions of people living with a serious chronic disease? Join Novo Nordisk, a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. We are looking for a dedicated EU Submission Lead for Clinical Trials to join...

  • Associate Regulatory Professional II

    1 week ago

    Bengaluru, India Novo Nordisk 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...

  • HR Professional I

    1 week ago

    Bengaluru, India Novo Nordisk Full time

    The position As an HR Professional I at Novo Nordisk, you will: Act as a Subject Matter Expert on all the tasks within the team. Organizational Management and Employee Profile – Employee data Life cycle maintenance (EC/SF & SAP HR – end user). Perform data to day activities according to defined KPIs and SOPs, follow internal guidelines/ policies....

  • Reporting Professional I

    3 weeks ago

    Bengaluru, Karnataka, India Swiss Re Full time

    About the role:Be able to complete all assigned quarterly & yearly BAU's to support the regulatory filing. Involve in and perform analysis of quarterly financial results for the Canadian Life & Health branch on IFRS 17 Assumption of additional projected-related responsibilities as well as ad-hoc requests from different teams within SwissRe Seeking...

  • Reporting Professional I

    3 weeks ago

    Bengaluru, Karnataka, India Swiss Re Full time

    About the role:Be able to complete all assigned quarterly & yearly BAU's to support the regulatory filing. Involve in and perform analysis of quarterly financial results for the Canadian Life & Health branch on IFRS 17 Assumption of additional projected-related responsibilities as well as ad-hoc requests from different teams within SwissRe Seeking...

  • Planning Professional

    4 weeks ago

    Bengaluru, India BT Full time

    Planning Professional **Job Req ID**:21049**Posting Date**:8 Aug 2023**Function**:Software Engineering**Location**:RMZ Ecoworld, Devarabeesanahal, Bengaluru, India**Salary**:Competitive**Why this job matters** The Planning Professional supports the planning, execution and implementation of release processes across Agile teams, thoroughly escalating...

  • Associate Regulatory Professional II

    1 week ago

    Bengaluru, India Novo Nordisk Full time

       Department: EU Submissions Hub Are you ready to make a difference in the lives of millions of people living with a serious chronic disease? Join Novo Nordisk, a proud life-science company on a mission to ensure that people living with a chronic disease can live a full life. We are looking for a dedicated EU Submission Lead for Clinical Trials to join...

  • Regulatory Specialist

    7 days ago

    Bengaluru, India Novo Nordisk AS Full time

    Department: Regulatory Affairs Rare Endocrine Disorders Are you passionate about ensuring regulatory compliance for early phase products and/or managing product life cycle and amendments? Do you want to play a crucial role in keeping patients safe and ensuring Novo Nordisk’s license to operate by supporting in creating regulatory strategies? We...