Regulatory Affairs Manager (Team Manager)

Are you highly motivated by being able to make a difference to improving patients’ lives? Are you a high performing executive who energized by challenges and able to energize people around you? If so, continue reading and apply today!
In Novo Nordisk Korea, the position of Regulatory Affairs Manager provides you the opportunity to work in a high performing team to contribute directly towards the business results while creating values for the Diabetes patients.

About the department

Within our Regulatory Affairs Team, we have now 8 team members who use our skills, dedication and ambition to achieve our team’s goal. Now we’re looking for competent Regulatory Affairs Manager who will bring more synergy to the company. In exchange, we offer the chance to be part of a highly specialized business in a global healthcare company, with respectful cultures and balanced work environment. 

The position

This position has been newly created as part of the team expansion and will report directly to the Regulatory Affairs & Pharmacovigilance Head. This position will lead a team of 4-5 members of (Sr.) regulatory affairs specialists.
As a Regulatory Affairs Manager, you will ensure products can be placed on the market with optimal yet compliant claims, and promotion in line with commercial plans, and ensure products are maintained and meet internal and external compliance requirements. You will lead the local regulatory affairs team and act as a proactive partner to other stakeholders, and also engage with the external regulatory environment and act as a responsible voice of Novo Nordisk with local regulators, trade associations and other key external regulatory bodies. The role will also proactively look for opportunities and solutions to challenges, including leading implementation of improvement initiatives, and provide input into regulatory strategies and process improvement/compliance activities.

The role tasks include but are not limited to: 

• Lead/oversight preparation of new regulatory documents, dossiers, and applications to enable new products to be launched and maintained in the market, with the correct alignment and compliance to regulations, proactively seeking innovative and rapid path to market. Analyse regulatory issues and communicate effectively with key stakeholders, including global colleagues. Lead development of strategies and plans to mitigate, so that we can deliver products backed by science that are robust and aligned with business needs.
• Actively contribute to high performing teams, including looking for ways to improve performance. Lead direct reports and/or cross-functional teams within local market.
• Build relationships with key stakeholders and represent Novo Nordisk in a responsible manner according to company values, in order to communicate Novo Nordisk policies and strategies and negotiate outcomes. Manage compliance within portfolio/activity streams in line with Novo Nordisk expectations. Propose solutions to identified issues and implement.
• Collaboratively work together with other functions (e.g., marketing, supply chain) as a functional leader from RA to deliver NDA (New Drug Application) and value engineering projects. Support the development of the strongest claims and promotion possible within the regulations, ensuring risks are appropriately addressed and communicated.
• Proactively identify potential regulatory risks and manage impact of regulatory changes within defined scope of responsibility on the business and beyond to support RA&PV Head. Maintain required regulatory compliance databases, systems and processes. Train other company stakeholders as required. Maintain high level of knowledge on the science of products. Have daily independent communication with MFDS (Korean Ministry of Food and Drug Safety) and other teams/departments regarding the assigned tasks.

 
Qualifications

• Must hold a pharmacist license and has 9+ years of work experience in the regulatory submissions/approvals
• Experience in people management is preferred.
• Regulatory experience in a multinational company is a plus
• Possesses strong strategic thinking, stakeholder management, and problem-solving skills
• Demonstrates a good command of English and exhibits persuasive and impactful communication

Working at Novo Nordisk
At Novo Nordisk, we don’t wait for change. We drive change. 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 shy away from opportunities to develop, we seize them. Working at Novo Nordisk is working toward something bigger than ourselves, and it’s a collective effort. Novo Nordisk relies on the joint potential and collaboration of its more than 40,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases.
 

Contact

Kindly upload your CV to our online career page (click on Apply and follow the instructions).

Deadline

Until the completion of recruitment.
Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.

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.

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