About this opportunity
Estamos em busca de um(a) Analista Sênior de Assuntos Regulatórios para atuar na gestão das atividades regulatórias de medicamentos sintéticos e biológicos. Esta posição é responsável por garantir a conformidade com as regulamentações sanitárias locais, apoiar processos de registro e renovação de produtos e colaborar estreitamente com equipes regulatórias globais.
O que você fará
Preparar e submeter à ANVISA dossiês de registro de novos produtos, alterações pós-registro, renovações e demais processos regulatórios.
Atuar como principal ponto de contato para responder às exigências da ANVISA e acompanhar o andamento das análises dos dossiês.
Revisar e aprovar materiais promocionais utilizando a plataforma Veeva.
Gerenciar atualizações de bula e rotulagem com base em alterações do Core Data Sheet (CDS) global.
Apoiar inspeções e renovações de certificações de Boas Práticas de Fabricação (BPF/GMP) de plantas produtivas internacionais.
Monitorar informações regulatórias, incluindo consultas públicas, resoluções sanitárias e atividades da concorrência.
Manter bases de dados regulatórias e documentação atualizadas.
Colaborar com equipes multifuncionais e participar de reuniões regulatórias internacionais.
Quem você é
Você é uma pessoa organizada, detalhista e proativa, capaz de trabalhar de forma eficaz sob pressão. Demonstra sólida capacidade de análise regulatória, excelentes habilidades de comunicação e forte colaboração com diferentes áreas da organização.
Requisitos
Graduação em Farmácia, Bioquímica ou áreas correlatas.
Experiência em Assuntos Regulatórios.
Conhecimento sólido das regulamentações da ANVISA para produtos sintéticos e biológicos.
Inglês avançado (oral, escrito e leitura).
Domínio das ferramentas do Microsoft Office.
Diferenciais
Experiência com regulamentação de medicamentos genéricos.
Participação prévia em inspeções de Boas Práticas de Fabricação (BPF/GMP).
Job Level: Professional
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Job details
How this role compares
Computed from every other active Regulatory Affairs role in our database, not just this employer's listings.
We currently track 585 comparable Regulatory Affairs roles across 112 biopharma companies.
Salary context
157 of 585 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 585 comparable roles
+ 46 more countries
Seniority mix
455 of 585 peers have a known seniority level
Therapeutic area mix
43 of 585 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Open in 3 locations
Matched on job function only -- seniority, specialty, and location weren't confirmed as aligned.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
Or follow a whole field: get every new Regulatory Affairs job in Brazil, and choose locations and companies.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.