Senior Manager, Regulatory Affairs Operations responsible for regulatory submissions in a biotechnology firm. Overseeing documentation, compliance, and cross - functional collaboration for FDA and EMA submissions.
About the role
- Compliance Analyst conducting Due Diligence analyses for decision-making support. Collaborating with different departments to ensure compliance and integrity in corporate practices.
Responsibilities
- Conduct reputational analyses of third parties (Due Diligence), issue technical opinions, assess risks and propose mitigation plans.
- Collect, organize and interpret public and private information about suppliers, partners and service providers.
- Perform Conflicts of Interest analyses and support the management of the annual campaign on the subject.
- Monitor and follow up on responses to PEP (Politically Exposed Persons) and conflicts of interest declarations, contributing with the Consultant to define action plans to mitigate risks.
- Assist in drafting and reviewing internal policies and procedures for business areas, ensuring compliance with regulatory requirements and integrity best practices.
- Support the Mid-level Analyst in responding to regional directorates and procurement areas on matters related to the Due Diligence process.
- Identify and flag potential reputational, legal or integrity risks in relationships with third parties.
- Support the Compliance Consultant in organizing, tracking and following up on documents related to the investigation of complaints.
- Conduct content research to support training and institutional communications.
- Monitor and follow up on responses to PEP and conflicts of interest declarations and, together with the consultant, develop action plans to mitigate risks.
- Act as a culture ambassador, promoting ethics, transparency and compliance at all organizational levels.
- Proficient with Microsoft Office suite, with advanced knowledge of Excel.
Requirements
- Bachelor’s degree in Law, Business Administration, Accounting or related fields.
- Previous experience at a Big Four firm and registration with the Brazilian Bar Association (OAB).
- Experience using Aliant and Neoway tools.
- Participation in corporate investigations or support in investigation of complaints.
- Analytical profile, with discretion, diligence, a strong sense of responsibility, critical thinking and agility in problem solving.
- Excellent verbal and written communication skills, with the ability to lead meetings and presentations.
- Comfortable interacting with different departments and hierarchical levels.
- Proactive and results-oriented.
Benefits
- Food allowance.
- Meal voucher.
- Health plan.
- Breakfast provided at the unit.
- Access to the company country club.
- 25% discount at Centro Universitário São Camilo.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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