Job Description

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Principal specialist - Global RA CMC Lead

Category: Reg Affairs & Safety Pharmacovigilance

Location:

Bangalore, Karnataka, IN

Department: RA CMC

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 \xe2\x80\x9cPrincipal specialist/Global RA CMC Lead\xe2\x80\x9d 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 \xe2\x80\x9cout of the box\xe2\x80\x9d, 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. So, look forward to being surrounded by talented, cooperative, and embracing teammates in a strong and empowering culture filled with humble people.

The Position

As Principal specialist/Global RA CMC Lead, the candidate should have proven subject matter expertise within several of the main job tasks as listed below. Manages field of expertise that requires highly specialised knowledge of strategic importance to the SVP area. Recognised as an expert in own area within the organisation and perceived as expert within one or several key processes across an SVP area. Requires specialised depth and/or breadth of expertise. Interprets internal or external business issues and solutions. Recommends solutions/best practices. Solves complex problems; takes a broad perspective to identify. Requires strong pharmaceutical industry knowledge and understanding. Act as mentor for senior colleagues within field of expertise.

This position commands in developing business acumen, enable strategy and lead through uncertainty while building strategic partnership with stakeholders.

• Accountable for the overall RA CMC regulatory strategy in alignment with Product supplies and other key stakeholders
• Represent RA function in RA matrix team, ensuring alignment of planning and strategy across areas
• Facilitate dialogues between our project teams and health authorities around the globe with focus on our existing/innovative CMC aiming to provide medicinal products with not just high quality, efficacy and safety, but also with best patient\'s usability
• Be able to balance LoB and Core team/GPT member responsibility (as and when needed) and ensure timely delivery of tasks
• Communicate project direction to Novo Nordisk governance in collaboration and agreement with PVP/CPVP
• Excellent communication skills required including communication and presentation of ambiguous and complex data along with ability to provide convincing arguments within subject matter expert area across the functional area
• Define best in class regulatory CMC strategies for biopharmaceuticals/combination product thereby ensuring fast submissions and approvals globally.
• Add value by identifying and developing better practice and creating improvements in methods, processes and approaches related to regulatory documentation and strategies
• Contribute in regulatory intelligence signals analyses for regulated and semi/non regulated markets, exploring differentiated regulatory pathways like reliance pathways, ICHQ12, for securing faster approvals and down classification of change category
• Strong Stakeholder management.

Qualifications

• 15+ years of overall regulatory CMC experience out of which minimum 2-5 years in strategic CMC role and/or CMC lead position
• Graduate/Postgraduate degree in Life-Science/ Chemistry/ Pharmacy/ Medicine.
• Experience of working both in Global & Affiliate environment will be preferred.
• Interaction with European medicines agencies, US FDA and other key agencies.
• Good understanding of end-to-end Regulatory processes and Life Cycle Management.
• 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.
• Excellent written/spoken communication skills.
• Proven track records of excellent project management, Strong negotiations, influencing and leadership skills
• Proficient in RA process and IT systems (Veeva Vault)

Working At Novo Nordisk

At Novo Nordisk, we are driving change to defeat diabetes and other serious chronic conditions. Our treatments today are benefiting millions of people living with diabetes, obesity, and rare blood and endocrine diseases. From our labs to our factory floors, we are discovering and developing innovative biological medicines and making them accessible to patients throughout the world. Since the company was founded in Denmark more than 100 years ago, we have been translating the unmet medical needs of people living with serious chronic diseases into innovative medicines and delivery. Our focus is on these diseases, which affect hundreds of millions of people and are among the most urgent global health challenges. By combining our innovation and commercial excellence, we draw upon insights from patients and partners to transform bold ideas into life-saving and preventive medicines. Our ambition is to take the lead in each of these areas, driving change with an unfailing belief that it can be done.

Contact

If you believe you are a match for the above requirements and are highly motivated to take up the role, please apply here with our online application tool.

Deadline

Apply on or before: 6th March 2024

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.

Novo Nordisk