Summary
Overview
Work History
Education
Skills
sections.external_links.name
Certification
Languages
Timeline
Generic
Carolina Franklin Halembeck

Carolina Franklin Halembeck

São Paulo,Brazil

Summary

I am a certified Legal and Compliance professional with 15+ years of professional experience in supporting highly regulated industries to navigate complex legal and compliance environments. My core competencies include being a strong business partner, developing, implementing, restructuring and simplifying compliance programs and data privacy governance, providing general legal advice, drafting and negotiating contracts, managing strategic litigation and patent defense. I have contributed to global projects and initiatives, working with cross-functional teams and stakeholders across different regions and cultures, ensuring legal and compliance solutions to support business needs.

Overview

20
20
years of professional experience
6
6
years of post-secondary education
1
1
Certification

Work History

Legal and Compliance Counsel

Halembeck Associados
São Paulo, Brazil
09.2020 - 12.2024
  • Legal and Compliance consultant for the Life Science, Biotech, Pharmaceutical and Medical Device Industry
  • Navigated intricate laws and regulations, safeguarding client interests at all times.
  • Established trusting relationships with clients through consistent communication and transparency.
  • Contributed significantly to business development initiatives, attracting new clientele for the firm.
  • Handled sensitive information with utmost discretion, maintaining strict confidentiality protocols.
  • Stayed abreast of latest developments in law, ensuring accurate advice provision to clients.
  • Advised corporate clients on a range of commercial issues to avoid potential legal pitfalls.
  • Built productive partnerships with legal aid firms to enable rapid progress of referral cases.
  • Delivered initial legal advice to help clients recognise appropriate case pathways.
  • Managed and oversaw paralegals and legal assistants.
  • Offered helpful, informative legal advice to clients, colleagues and external practitioners.
  • Interpreted laws, rulings and regulations for businesses and individuals.

Board Member, Legal Secretary, Head of Compliance Committee, Legal Advisor for Latam

Celgene
São Paulo, Brazil
06.2019 - 06.2020
  • Responsible for providing support to the business in all legal and compliance related matters: policies and procedures, monitoring, trainings, risk assessment, risk management, compliance committee, due diligence of TPIs, investigations and consulting
  • Support during corporate audit, implementation of CAPAS and data privacy governance
  • Support to the business during transition period after acquisition by BMS
  • Developed governance strategies to ensure company compliance and integrity.
  • Chaired committee meetings for productive discussions and deliberations.
  • Spearheaded the development of new policies, ensuring regulatory adherence.
  • Mitigated risk factors with diligent oversight and auditing procedures.
  • Nurtured a culture of transparency to foster trust within the team.
  • Collaborated on business plans, resulting in successful execution of projects.
  • Influenced organisational direction through informed voting on key issues.
  • Ensured statutory compliance, safeguarding company's reputation and operations.
  • Fostered an environment conducive for innovation, stimulating company growth.
  • Facilitated constructive discussions during board meetings, fostering collaboration and harmony among members.
  • Offered long-standing professional expertise to devise strategic business plans and drive company growth.
  • Monitored industry landscapes to make technical and operational recommendations.
  • Delivered guidance and strategic support to executive team.
  • Maintained organisational compliance with applicable legislation and regulations.

Director of Compliance

Gilead Sciences
São Paulo, Brazil
01.2018 - 06.2019
  • Board member, Head of the Compliance Committee
  • Responsible for providing support to the business in all compliance related matters: policies and procedures, monitoring, trainings, risk assessment, risk management, compliance committee, due diligence of TPIs, investigations and consulting
  • Implementation of data privacy governance
  • Leader of a global project for the implementation of compliance monitoring and support to the business on strategic patent litigation
  • Elevated compliance standards by implementing robust policies and procedures.
  • Ensured legal adherence for smooth business operations.
  • Fostered a culture of integrity with consistent training sessions.
  • Conducted audits, ensured transparency in all processes.
  • Streamlined communication channels for prompt issue resolution.
  • Provided expert guidance to the board on regulatory matters.
  • Coordinated investigations into alleged breaches of regulations or ethics.
  • Managed a team of compliance officers to achieve organisational goals.
  • Reviewed company practices and documents for legality assurance.
  • Supervised operations, ensured adherence to laws and guidelines.
  • Identified areas of non-compliance through regular monitoring activities.
  • Developed risk management strategies, safeguarded against potential threats.
  • Promoted ethical conduct with the establishment of appropriate controls.
  • Improved operational efficiency by streamlining compliance protocols.
  • Evolved training programmes, enhanced staff understanding of complex regulations.
  • Monitored operations to assess and highlight results.
  • Maintained organisational compliance with applicable legislation and regulations.

Latam Compliance Director

Biogen
São Paulo e Região
01.2016 - 08.2017
  • Responsible for restructuring the compliance program in Latin America (Brazil, Argentina and Mexico) and providing support to the business in all compliance related matters: policies and procedures, monitoring, trainings, risk assessment, risk management, compliance committee, due diligence of TPIs, investigations and consulting
  • Responsible for implementing compliance monitoring
  • Managed compliance risk by implementing effective regulatory strategies.
  • Formulated policies for mitigating potential compliance issues.
  • Achieved enhanced efficiency with thorough audits and reviews.
  • Conducted training sessions to ensure understanding of compliance regulations.
  • Designed systems, improved operational effectiveness.
  • Streamlined processes to achieve optimum compliance standards.
  • Reviewed company contracts, ensured legal adherence.
  • Identified potential risks with appropriate mitigation strategies.
  • Developed innovative solutions, resolved complex regulatory challenges effectively.
  • Created robust internal controls to prevent non-compliance incidents.
  • Supported design, development and implementation of different compliance processes.

Legal & Compliance Senior Manager Latam

Mundipharma
Sao Paulo
02.2014 - 01.2016
  • Responsible for implementing a Legal & Compliance program in Brazil, Mexico, Colombia and Argentina, where Mundipharma started direct operations
  • Responsible for drafting and negotiating all pharma related contracts such as HCP service agreements, distribution agreements, supply agreements, NDA and purchase agreements
  • Responsible for conducting compliance internal investigations
  • Negotiated major contracts, achieving favourable terms for the company.
  • Successfully managed risk assessment procedures by adopting industry best practices.
  • Built strong partnerships with stakeholders for mutual benefit.
  • Ensured regulatory compliance through meticulous auditing procedures.

Legal & Compliance Manager Brazil

Carestream
São Paulo e Região
03.2012 - 02.2014
  • Compliance, Contracts, Corporate Law, Labor, Tax, Litigation
  • Responsible for managing the two major litigation cases of the Company in the world with a positive outcome
  • Ensured adherence to regulatory requirements by implementing sound compliance programmes.
  • Collaborated with senior management to establish effective compliance policies and procedures.
  • Reviewed contracts and agreements to ensure consistency with relevant laws, regulations, and company policies.
  • Provided expert guidance on regulatory matters during the decision-making process at board meetings.
  • Monitored changes in relevant legislation, ensuring timely updates to company policies as needed.
  • Played a vital role in fostering an environment that promotes ethical conduct and commitment to compliance obligations.
  • Collaborated with multi-disciplinary staff to instill culture-wide culture of accountability and compliance.
  • Supported creation of training materials to educate employees on regulations and impact of non-compliance.

Sênior Legal Counsel

Votorantim S.A.
São Paulo Area
12.2009 - 02.2012
  • Contracts, Corporate Law, M&A, Labor, Tax and strategic negotiations, as well as managing external councils in Brazil, Europe, USA, South Africa, LAR
  • Responsible for opening a branch office and mining operations in South Africa
  • Negotiated critical contracts for improved business partnerships.
  • Provided comprehensive legal advice, mitigating potential risks.
  • Handled high-profile mergers and acquisitions, facilitating seamless transitions.
  • Reviewed commercial agreements to prevent potential legal disputes.
  • Streamlined contract review process for improved efficiency and consistency.
  • Drafted and reviewed complex legal agreements and contracts.
  • Collaborated with external law firms on legal matters requiring specialised expertise.
  • Advised on compliance with anti-bribery and corruption laws and regulations.
  • Provided strategic legal advice on commercial transactions and regulatory compliance.

Associate Attorney

Linklaters
06.2007 - 05.2008
  • Corporate Law, Contracts, M&A, Labor, having advised clients such as J&J, GM, Varig/Gol, Syngenta, Odebrecht, Al Khaleej, Senna, Ingenico and JCDecaux
  • Drafted and reviewed contracts for improved legal protection.
  • Advised clients on diverse legal matters to inform decision-making process.
  • Coordinated meetings with clients for case updates and consultations.
  • Maintained up-to-date knowledge of recent legislations, ensuring accurate advice provision.
  • Delivered initial legal advice to help clients recognise appropriate case pathways.
  • Managed and oversaw paralegals and legal assistants.
  • Interpreted laws, rulings and regulations for businesses and individuals.

Attorney

PwC
03.2005 - 03.2007
  • Contracts, Corporate, M&A, Due Diligence, having advised clients such as Cargill, Bodycote, Maeda e PwC
  • Navigated intricate laws and regulations, safeguarding client interests at all times.
  • Prepared detailed reports on case progress to keep clients informed and reassured.
  • Established trusting relationships with clients through consistent communication and transparency.
  • Stayed abreast of latest developments in law, ensuring accurate advice provision to clients.
  • Advised corporate clients on a range of commercial issues to avoid potential legal pitfalls.
  • Delivered initial legal advice to help clients recognise appropriate case pathways.

Education

SCCE - CCEP-I - Compliance

Society of Corporate Compliance and Ethics
United States
06.2014 - 07.2014

LLm - Corporate Law

Insper
São Paulo, Sao Paulo
01.2012 - 06.2013

Bachelor of Laws - LLB - Corporate Law

USP - Universidade de São Paulo
São Paulo, Sao Paulo
01.2000 - 12.2004

Skills

  • Solid Legal Advice
  • Strategic Negotiations
  • Health Care Compliance
  • Strategic Litigation
  • Data Privacy

Certification

SCCE

Languages

English
Proficient (C2)
French
Advanced (C1)
Spanish
Proficient (C2)
Portuguese (Native or Bilingual)
Native

Timeline

Legal and Compliance Counsel

Halembeck Associados
09.2020 - 12.2024

Board Member, Legal Secretary, Head of Compliance Committee, Legal Advisor for Latam

Celgene
06.2019 - 06.2020

Director of Compliance

Gilead Sciences
01.2018 - 06.2019

Latam Compliance Director

Biogen
01.2016 - 08.2017

SCCE - CCEP-I - Compliance

Society of Corporate Compliance and Ethics
06.2014 - 07.2014

Legal & Compliance Senior Manager Latam

Mundipharma
02.2014 - 01.2016

Legal & Compliance Manager Brazil

Carestream
03.2012 - 02.2014

LLm - Corporate Law

Insper
01.2012 - 06.2013

Sênior Legal Counsel

Votorantim S.A.
12.2009 - 02.2012

Associate Attorney

Linklaters
06.2007 - 05.2008

Attorney

PwC
03.2005 - 03.2007

Bachelor of Laws - LLB - Corporate Law

USP - Universidade de São Paulo
01.2000 - 12.2004
Carolina Franklin Halembeck