Associate Manager, Regulatory Affairs

PLEASE SUBMIT ALL RESUMES/CV'S IN ENGLISH FOR CONSIDERATION

Location: Sao Paulo Hybrid

Language Requirement: English required and Spanish is a plus.

Required Experience: Pharmaceutical/Biotech Industry

General Description:
This position will be responsible for coordinating the drug registration process in timely and efficiently from beginning to end in accordance with regulatory requirements and coordinate regulatory activities between cross-functional teams.

Essential Functions:

- Prepare, submit and support New Product and Line-Extension submissions.
- Prepare, submit and support Post-Approvals Changes, Annual Product Review and Product Renewals process.
- Obtain successful regulatory submission and approval of new products and be compliant and effective with all product safety activities in Brazil.
- Coordinate and oversee all relevant maintenance activities including Life Cycle Management strategy with compliance with the relevant law and internal procedures.
- Collaborate and communicate effectively with teams internally and external bodies to meet business objectives.
- Maintain up-to-date knowledge of relevant regulations, including proposed and final regulations and provides regulatory affairs related information to other divisions and department
- Provide expert regulatory input to strategic decision making, including portfolio review, prioritization, and external communications.
- Formulate and implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained
- Ensure registered products are maintained and updated in full compliance with all relevant legislation and SOPs, etc.
- Assist Regulatory Country Head in managing activities such as audits, regulatory agency inspections, or product recalls, etc.
- Assist Regulatory Country Head in coordinating regulatory activities across divisions.
- Assist Regulatory Country Head in maintaining all company operating licenses valid with local Health Authority and Anvisa.
- Management of Package Insert Updates (CCDS) to cope with Anvisa and company compliance.
- Regulatory Intelligence: Legislation (local and regional deployment, working group, trainings) and Product (competitors monitoring).
- Active participation in Pharmaceutical Entities (Interfarma/Sindusfarma) - Shaping Environment

Minimum Requirements - Education and Experience:

- Pharmacy Degree from an accredited Brazilian University
- Minimum 4 years of work experiences in regulatory affairs in pharmaceutical Industry

Other Qualifications:

- Strong knowledge of current Brazil regulations
- Fluency in written and spoken English
- Planning/Organizing oriented, demonstrate initiative, communication and interpersonal skills.

Supervisory Responsibilities: N/A

Travel: 5% or less

Computer Skills:

- Microsoft Office & Outlook

LI-Remote

BeiGene Global Competencies

When we exhibit our values of Patients First, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity

We are proud to be an equal opportunity employer and we value diversity. BeiGene does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.