Affiliate Regulatory Affairs Portfolio Manager

**The Position**

Responsible for compiling, submission and approval activities for New Drug Application (NDA), renewals, and Life Cycle Management (LCM) licences under supervision of RA Manager. Monitor local regulatory environment and ensure compliance. Develop local labelling and ensuring the regulatory compliance in promotional material.

The position holder will also provide support to the local RA Manager in training RA employees.

Your key responsibilities include:

- Monitor local regulatory environment and ensure regulatory compliance; interact constantly with Health Authorities (HAs) to ensure timely approvals, detect regulatory trends and keep up-to-date with legislation at affiliate.
- Responsible for compiling, submission and approval of NDA and LCM licences; manage the compilation and preparation of regulatory documents, information, data technical files to support approvals for new product registration, renewals and changes (NDA and LCM licenses):

- Support in developing labelling materials and review/approve promotional materials; review the promotional materials to ensure overall legal compliance with HA’s requirements.
- Provide regulatory support and insight to key stakeholders; provide advice and recommendations to local RA Manager at local level on regulatory policy and applicable strategy in order to accelerate regulatory approvals while securing compliance.
- Internally, collaborate with other departments in the affiliate (Marketing, Legal, Logistics, Sales) providing them with information of regulatory matters when necessary.

**Qualifications**

To be successful in this role, you need to have University degree, preferably related to pharmaceutical studies/ Bachelor’s Pharmacist degree.

To be effective in this role, we expect you to have:

- Minimum 1 year experience in the Regulatory as an RA Associate
- Knowledge of local legislation
- Stakeholder management skills
- Business & Industry Insight knowledge

In this role we would expect you to have the ability to make things happen, with a proactive and team player attitude.

**About the Department**

The Regulatory department at Novo Nordisk is one of the most diverse and collaborative groups within the organization. From regulator and industry interactions, developing and implementing regulatory strategies, supporting new product launches, and new product submissions through their life cycle, the Regulatory team provides regulatory compliance of marketed and non-marketed products of high quality.

**Working at Novo Nordisk**

Novo Nordisk is its people. We know that life is anything but linear and balancing what is important at different stages of our career is never easy. That’s why we make room for diverse life situations, always putting people first. We value our employees for the unique skills they bring to the table, and we work continuously to bring out the best in 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 60,000 employees. Together, we go further. Together, we’re life changing.

**Contact**

**Deadline**

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

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.