Senior Regulatory Affairs Specialist

1 semana atrás

São Paulo, São Paulo, Brasil Tata Consultancy Services Tempo inteiro

Come to one of the biggest IT Services companies in the world Here you can transform your career

Why to join TCS? Here at TCS we believe that people make the difference, that's why we live a culture of unlimited learning full of opportunities for improvement and mutual development. The ideal scenario to expand ideas through the right tools, contributing to our success in a collaborative environment.

We are looking for Senior Regulatory Affairs , who wants to learn and transform his career.

In this role you will:


• Ensure quality and compliance in all my actions by:


• Attend GMP training on the schedule designated for my role and as appropriate for my role


• Adhere to strict compliance with procedures applicable to my role.


• Exercise the highest level of integrity in the tasks that I perform


• In a timely and prompt manner, identify, report and seek correction for deviations noted in my workplace.


• Embrace a behavior of employee involvement and commitment to doing the job right the first time.


• If a People Manager:


• Ensure employees under your scope of responsibility are trained in required procedures for the execution of their role and maintain current with training requirements during the year.


• Promote an environment of employee involvement in the workplace.


• Seek prompt identification, reporting and correction of deviations in the workplace as noted by employees.

And much better if you stand out for:

Education: A minimum of a bachelor's degree in relevant health-related scientific discipline or an advanced degree in a related field is preferred. PhD in organic chemistry is preferred.

Experience: Experience assessing API drug master file from technical-regulatory point of view. Deep knowledge in Quality ICH guidelines, M4-CTD, M7-mutagenic impurities and nitrosamines is required. Large experience with small molecule/NCE is required, as well knowledge in elemental analysis, NMR spectroscopy, IR spectroscopy and LC-MS analysis. Experience authoring and compiling parts of Module 3 CMC sections is preferred.

Knowledge, Skills and Abilities:Knowledge/familiarity with Brazil and Mexico regulatory registration of drugs, API regulatory framework (CADIFA) is required. Excellent verbal and written skills and the ability to work effectively in a team-oriented, matrix environment are required. Experience interacting with health authorities is preferred. The position must have the ability to work independently, manage several complex projects/issues in parallel, and effectively influence others in a cross-functional team setting with a solution-oriented and enterprise mindset. Experience interacting with relevant trade associations or serving on trade association committees is preferred.

Certifications/Licenses: Regulatory Affairs Certification (RAC) (optional)

Advanced English

Desirable Skills:

Primary responsibility is to manage/develop the successful coordination, compilation, submission and approval of API Drug Master File to the LATAM regulatory agencies (ANVISA and Cofepris).

May be required to train and supervise contract resources.

This position will work closely with management and cross-functional partners to develop regulatory strategies and various submission packages throughout the development process and through filing and post approval. Execute CMC regulatory strategies for drug master file with internal research and development, and other technical/scientific colleagues. Collaborate and influence decisions in a highly matrixed organization, as well as in cross-functional team settings.

What do we offer?

  • Benefits – Brazil:
  • insurance
  • Plan
  • insurance
  • vouchers
  • Voucher
  • assistance
  • Cares – free 0800 that provides psychological assistance (24 hrs/day), legal, social and financial assistance to associates
  • with SESC
  • of Certifications
  • TCS Learning Portal – Online courses and live training
  • experience opportunity
  • Partnership with Universities and Language Schools
  • Your Buddy – By referring people you become eligible to receive a bonus for each hire
  • Gems – Recognition for performance
  • – Free Mentoring Career Platform

At TATA Consultancy Services we promote an inclusive culture, we always work for equity. This applies to Gender, People with Disabilities, LGBTQIA+, Religion, Race, Ethnicity. All our opportunities are based on these principles. We think of different actions of inclusion and social responsibility, in order to build a TCS that respects individuality. Come to be a TCSer

#Buildingonbelief

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