Analista de Assuntos Regulatórios Júnior (Prazo Determinado 12 meses)

Beschreibung:

JOB SUMMARY
Under close supervision of line management and/or guidance from an experienced Regulatory Manager or Coordinator, support and conduct agreed regulatory activities for assigned products and markets to obtain and maintain Marketing Authorisations, in line with business goals, legal requirements, internal procedures, and in partnership with above-country operational hubs.

Job Responsibilities

Support Regulatory Strategy and Cross-Functional Team Advice
· For assigned product and market responsibilities and under close supervision of line management or guidance from an experienced Regulatory Manager or Coordinator, support the development and implementation of regulatory strategies to support local business and R&D goals for licensed and development products.
· Participate in cross-functional product team activities, support Regulatory representation as appropriate, and help keep cross-functional colleagues and key stakeholders informed of progress with regulatory submissions.
· Under close supervision of line management or guidance from an experienced Regulatory Manager or Coordinator, work with above-country strategists to help provide country input into Global and Regional regulatory strategies as required.
· Build personal expertise through supervised support for assigned products within one or more therapy areas and one or more countries.
Provide Regulatory Advice and Information to meet Customer and Cross-Divisional colleague requests
· Develop knowledge of national legislation, guidelines and regulatory environment and how to use this to support responses to enquiries from Pfizer colleagues in other functions under the direction of line management or with support from a Regulatory Manager or Coordinator.
· Use this developing knowledge, with appropriate manager or coordinator support, to contribute to advice on matters of compliance, national regulatory requirements and Pfizer regulatory policy.
Support New Registration/Marketing Authorisation Applications: National Applications
· Support the preparation of submission strategy proposals for line management review and partner with above-country operational hubs and above-country strategists, under guidance, to obtain new product licenses.
Support Marketing Authorisation (MA) Variation Applications
· Support the triggering and monitoring of locally driven submission demands (e.g. NRA queries and requests for local label updates), under guidance.
· Support the assessment of regulatory impact, contribute to filing strategy alignment with other business functions as appropriate, participate in risk-based reviews with above-country hubs, and help communicate locally triggered delays and risks impacting the submission/approval to above-country and in-country stakeholders.
· Work with above-country strategists and above-country operational hubs, under guidance, to supply country documentation/information for dossier build as applicable.
· Support communication of NRA decisions to relevant internal stakeholders as applicable.
Support MA Renewal Applications
· Support agreement of filing strategy with relevant stakeholders as appropriate and participate in risk-based reviews of plans with above-country hubs, under guidance.
Support Management of NRA Queries
· In partnership with above-country operational hubs and above-country strategists, support the preparation of responses to NRA queries, under manager or coordinator guidance.
External Relationships
· Develop knowledge of NRA expectations, ways of working, etc., to support assigned product regulatory strategies. Share updates and regulatory intelligence with colleagues as appropriate.
· Support requests for authority advice/clarification when regulatory position is unclear and answers are not available through internal network, under manager or coordinator guidance.
· Support prompt and accurate responses to spontaneous requests from authorities, with appropriate review and approval.
Populate and Maintain Regulatory Databases
· Perform database entry and document management for regulatory transactions undertaken by Country Regulatory Strategists, in line with global SOPs and with appropriate guidance, if applicable and not performed by above-country operational hubs.
Safeguard Compliance in the Management of Packaging and Prescribing Information Component Updates
· Via defined procedures, support notification to relevant internal stakeholders of NRA approval of changes to packaging components and prescribing information and the timelines for associated implementation activities.
· Support the evaluation and preparation of requests for extensions to packaging artwork implementation with Regulatory Authorities when applicable, under guidance.
Support MA Divestments, MA Cancellations, Product Discontinuations and Supply Continuity
· Divestments: Support advice to the business on regulatory activities required prior to divestment/transfer of licence. Support licence transfer.
· Discontinuations: Support liaison with local Commercial/Medical/Demand functions and contribute to advice on regulatory action required for discontinuation of a product in the country marketplace.
· Upon receipt of above-country endorsement to proceed, support applicable notification to NRA and other external stakeholders as required by national regulations.
· Cancellations: Upon receipt of in-country and above-country endorsement to proceed, support applicable notification/request to NRA, as required by national regulations.
· Support notification to relevant colleagues of approval of the licence cancellation.
· Interruptions to Supply: Support notification to Regulatory Authorities of interruptions to supply in accordance with national regulations and as agreed with cross-functional team.
· Work with cross-functional team to explore options to help minimise or mitigate the out of stock. Support the process to obtain the necessary NRA approval as required and partner with above-country Operational Hubs as applicable.
Support Third Party Licences
· Support relevant local regulatory activities related to third party licences for which Pfizer has a contractual obligation, in accordance with applicable business agreements and Pfizer SOPs.
Contribute to Good Regulatory Practice (GRP)
· Adhere to relevant procedures and practices (SOPs, Job Aids and WIs) to ensure GRP is maintained.
· Support identification of changes to business processes to improve them as necessary, including to reflect changes in regulations.
· Through maintenance of regulatory activities in line with company procedures for assigned products, contribute to an inspection ready state.
Support Regulatory Group Development
· Contribute to and support as necessary the maintenance and development of the cluster/country Regulatory team through pro-active involvement and participation in team activities and special projects, under guidance; e.g. development of new operating procedures.
· Support drive towards Pfizer and GRS Vision and Values.
Manage Own Personal Development
· Identify own training and development needs in discussion with Manager to ensure a broadening skill and knowledge base and to maximise/optimise career development and contribution to the business.
· Develop product and therapeutic area knowledge as needed, according to product responsibilities list.
· With close support of line management, build on competency strengths and address any development areas.

Qualifications / Skills

Qualifications
* Certifications: N/A
Education: Pharmacist
Experience: Previous experience as regulatory Sciences intern

Skills
Technical: Technical-scientific knowledge of pharmaceutical products.
Good knowledge in English language.
Managerial: N/A

Organizational Relationships

· Commercial
· Medical
· Access and Value
· Quality
· Regulatory Law
· Regulatory International Operations
· Global CMC
· ILA
· PGS
· Global and International Regulatory Policy
· Legal
· Finance
· Trade Associations (Interfarma, Sindusfarma, and others)
· Brazilian Health Authorities

Other Job Details
* Work Location Assignment: On-site 2-3x/week or as needed by the business
* Last day to apply for job: August 5, 2026

EEO (Equal Employment Opportunity) & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, or disability.
To learn more about acceptable and prohibited uses of AI during the recruitment process, please review our candidate AI-use guidelines available on Pfizer Careers. Regulatory Affairs