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 Senior Regulatory Affairs Specialist 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 Senior Regulatory Affairs Specialist 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 Manager.
The job title of this position will be either RA Specialist or Sr. RA Specialist depending on the experience level of the candidate. This position is permanent.
As a Senior Regulatory Affairs Specialist, 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 be a productive part of a local regulatory team, including being 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 work together with regulatory colleagues and other stakeholders to 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 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. May lead 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) 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. Maintain required regulatory compliance databases, systems and processes. Train other company stakeholders as required to build knowledge and compliant utilisation. 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 5+ years of work experience in the regulatory submissions/approvalsWork experience in new product registration and GMP inspection is a mustRegulatory experience in a multinational company is a plusPossesses strong time management, analytical thinking, and problem-solving skillsDemonstrates a good command of English and exhibits persuasive and impactful communication
