Regulatory Affairs Analyst

**Regulatory Affairs Analyst (São Paulo/SP)**
As a Regulatory Affairs Analyst you will maintain an open and fluent communication flow with different external stakeholders on Affiliate level, preparing routine correspondence with regulatory agencies.
Also, you will collaborate with other departments in the affiliate (Marketing, Legal, Logistics, Sales) providing them with information of regulatory matters when necessary.
The incumbent will have to identify changes in the regulatory environment that might affect Novo Nordisk's local interests and positioning.
The position holder will suggest improvements and actions to adapt to those changes and will get involved in the innovation activities whenever asked to.
This position is based in São Paulo/SP
**The Position**
This person will be responsible for compiling, submission, and approval activities for New Drug Application (NDA) and Life Cycle Management (LCM) licences under supervision of RA Coordinator.
Monitor local regulatory environment and ensure compliance.
Develop local labelling and ensuring the regulatory compliance in promotional material.
Other activities include:
- Monitor local regulatory environment and ensure regulatory compliance.
- Supporting on Compiling, submission and approval of NDA and LCM licences.
- Developing labelling materials and review/approve promotional materials.
**Qualifications**
- Pharmacist / Biochemistry degree completed is mandatory;
- Fluent English is required;
- A of minimum 2 years ´ experience in the pharmaceutical/biotechnology industry and in particular R&D companies.
- Extensive knowledge and proven experience on post-registration changes / line extensions / labelling updates regulations, including GMP framework.
- Extensive experience in small molecules and biologics regulations.
- Experience in developing and implementing regulatory requirements and complex regulatory strategies.
**About the Department**
Area in direct contact with innovation, new therapies, best-in-class regulatory model.
Being part of our team, you could act as an agent of change, being part of the implementation of new therapeutic areas at Novo Nordisk.
Brazil is our biggest affiliate in LATAM, certified as Great Place to Work 2021.
Innovating and doubling its growth over the past years make us recognized as one of the most relevant companies on the health segment.
**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.
Together, we go further.
**Deadline**
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.