Regulatory Affairs Analyst (Black Community Inclusion)

At Novo Nordisk we don't wait for change, we drive the change. We're committed to promote and be an equal opportunity workplace and act as an affirmative action employer, as part of our continuous efforts to create and lead teams that have diversity and inclusion at their core. As part of that commitment, we advise you that we will prioritize candidates who self-identify as Black or Pardo throughout the entire selection process for this position.
Are you passionate about regulatory compliance? Do you have experience working with regulatory authorities or in the pharmaceutical industry? If so, you might be the perfect fit for our Regulatory Affairs Analyst position! Join us at Novo Nordisk and make a difference in ensuring the safety and efficacy of our products. Read more and apply today for a life-changing career.
The Position
This person will support in compiling, submitting, and approving New Drug Application (NDA) and Life Cycle Management (LCM) licences under the supervision of the RA Coordinator. They will monitor the local regulatory environment to ensure compliance and develop local labelling, ensuring regulatory adherence in promotional materials. This position is to work in São Paulo, SP.
Your responsabilities includes:

• Monitor the local regulatory environment, ensure compliance, and support NDA and LCM licence submissions and approvals.
• Develop local labelling, ensure regulatory compliance in promotional material, and maintain records on legislation, regulations, and guidelines.
• Conduct research on submission requirements, provide information on local regulatory needs to other departments, and assist in monitoring and reporting project timelines.
• Draft routine correspondence to regulatory agencies and manage regulatory archiving in accordance with local legislation and SOPs.
• Collaborate with other departments like Marketing, Legal, Logistics, and Sales, maintaining open communication and cooperation.
• Follow RA audits and manufacturing site inspections to ensure regulatory compliance.

Qualifications

• You hold a Bachelor's degree in health-related areas (e.g., Medicine, Pharmacy, Biology, Biomedicine).
• This person is expected to have Advanced level of English.
• We expect a candidate with experience with regulatory authorities or at an international pharmaceutical manufacturer.
• We'd like to see that you have experience in developing labelling materials and reviewing/approving promotional materials and familiarity with regulatory submission processes and requirements.

About the Department
We have a very collaborative, knowledge-sharing, and inclusive culture in Regulatory Affairs. It fits our vibrant, informal, and curious atmosphere perfectly. And combined with our critically analytical mindsets, intelligent use of technology, and our bold, innovative thinking, we achieve a great overview and a deep understanding of every step of the entire process. Our approach, culture and ways of working empower us to develop and grow as individuals and to improve and optimise our processes as a team - making our work and efforts valuable and impactful to both Novo Nordisk and the lives of our patients worldwide. Novo Nordisk is currently the market leader in Diabetes, Obesity and Growth Hormone. We are one of the fastest growing companies in Brazil for 3 years and we expect to continue achieving double-digit growth in the coming years.
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 69,000 employees to change the lives for the better for millions of patients living with diabetes and other chronic diseases. Together, we go further.
Deadline
Apply before October 13th, 2024.
Contact
To complete your application, please submit your CV by clicking "Apply now" and following the instructions. For more details, follow our LinkedIn page: Novo Nordisk: About | LinkedIn
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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.