Regulatory Affairs Professional

2 semanas atrás

São Paulo, São Paulo, Brasil beBeeRegulatory Tempo inteiro US$40.000 - US$60.000

The Regulatory Affairs area is pivotal for the company's growth. Through regulatory processes with health authorities, the organization expands and renews its portfolio. The regulatory environment is constantly evolving, requiring companies to be ready to anticipate changes, analyze their impacts, plan, and implement them in a timely and effective manner.

The Regulatory Affairs Intern should be prepared to work in this environment and deliver expected results through teamwork, quality, and close supervision. This role is in full compliance with applicable laws, regulations, policies, and procedures, including business rules and conduct and ethics guidelines.

This position includes but is not limited to collaborating with Regulatory Affairs team members in providing support to submissions of registration renewal, HMP, and low-mid complexity filings under close supervision. Tasks include:

  1. Registration renewal
  2. HMP (History of Modifications to the Products)
  3. New commercial presentation
  4. Cancellation of registration of drug product presentation
  5. New drug product shelf life
  6. Extension of shelf life for the drug substance/for the drug product
  7. Updating of specifications and analytical method of active ingredient, bulk product, finished product, adjuvant, and stabilizers not included in official compendium
  8. Inclusion of manufacturing site of the drug product in its primary/secondary packaging
  9. Deletion of the manufacturing site of the bulk drug product
  10. Deletion of the manufacturing site of the drug substance
  11. Inclusion of primary packaging
  12. Labeling text change
  13. Database correction request
  14. Official Gazette publishing correction request

Low complexity PAV filings are defined as those that do not need prior approval from health authorities. Mid complexity filings are properly defined in applicable regulations. In case of doubt, the regulation should be consulted.

This role also includes feeding BMS databases with accurate and updated regulatory records on a timely basis and collaborating with Regulatory Affairs team members to create local labeling in full adherence to target labeling strategy. Additionally, this role involves updating local labeling, creating and updating local packaging components, supporting the update of procedures, manuals, and work instructions, and providing regulatory information to partner areas.

Skills and qualifications for this role include:

  • Collaboration with Regulatory Affairs team members
  • Support to submissions of registration renewal, HMP, and low-mid complexity filings
  • Familiarity with BMS databases and regulatory records
  • Able to work in a fast-paced environment with multiple tasks and deadlines
  • Strong communication and teamwork skills

Benefits of working in this role include:

  • Opportunity to work in a dynamic and growing company
  • Chance to develop skills and experience in regulatory affairs
  • Collaborative and supportive team environment
  • Professional development opportunities

Others:

  • Connects and collaborates across local, regional, and global functions as required
  • Focused on patient and customer needs to drive results
  • Learns and shares best practices across the function
  • Demonstrates commitment to timely deliver quality results

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