Responsibilities
- Lead the preparation of regulatory documents, dossiers, and applications to enable new products to be launched and maintained in the market, ensuring proper alignment and compliance with regulations while proactively seeking innovative and rapid paths to market.
- Analyze regulatory issues and communicate effectively with key stakeholders, including global colleagues. Develop and lead strategies and plans to mitigate risks, ensuring delivery of scientifically robust products 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.
Requirements
- Must hold a pharmacist license and has 5-10 years of work experience in the regulatory submissions/approvals.
- Work experience in new product registration and GMP inspection is a must.
- Possesses strong time management, analytical thinking and problem-solving skills.
- Demonstrates a good command of English and exhibits persuasive and impactful communication.
Nice to Have
- Regulatory experience in a multinational company is a plus.
Additional Information
- Applications will be screened on an ongoing basis, so you are encouraged to apply as soon as possible.
- Novo Nordisk is currently in the process of adjusting job titles globally. Please note that the job title listed in this advertisement may be subject to change. More detailed information will be provided during the recruitment process.
