Legal and Compliance Director, GCC - Interim
Dubai

Everything we do at KKI, is rooted in the idea of leaping forward to make people smile. We are committed to innovation, for the benefit of the patients who count on us to support them. From medicines for rare and underserved diseases, to the support families need when facing a life-changing diagnosis – our team is proud of all we deliver, but also humble in knowing how much more needs to be done. By listening to patient stories, we gain a better understanding of the obstacles patients and their families face – so we can work to better meet their unique needs. The real proof of our impact is in the smiles we see on patients’ faces, when we have helped answer a need, or improved their well-being through our work. While the journey is not easy, it is one that is filled with purpose.

RESPONSIBILITIES

Legal

• Advise the GCC Cluster Leadership Team on appropriate business models for entering new markets.
• Ensure robust due diligence is carried out in the selection of 3rd parties. 
• As part of the International Legal Team supporting Kyowa Kirin’s growing businesses, the incumbent will be responsible for day-to-day legal matters in the GCC Region and will serve as member of the GCC Leadership Team.
• Full-fledged responsibility for legal affairs for GCC, including contract management, legal dispute management.
• Be an active and commercially-minded business partner and provide pragmatic and timely legal advice.
• Keep GCC Business Management aware of significant legal and corporate developments and trends in support of company business.
• Liaise with IP and regulatory colleagues to advise on likely exclusivity in new markets.
• Draw up and review contracts.
• Negotiate contracts with 3rd parties and enforce contractual provisions.

Examples of specific responsibilities include:

• General Business Support: Advice on general business related matters; advice on securing approval and reimbursement for company products; drafting and/or reviewing commercial agreements, including the appointment of distributors; advising on pharmaceutical advertising in the region and the suitability of promotional and non-promotional materials; litigation: provide advice and prepare relevant documents with external counsel.
• R&D/Medical Affairs Support: Support medical and scientific activities in GCC, including named patient programmes; draft and/or review sponsorship related agreements, including Consultancy Services Agreements, Advisory Board Agreements, Confidentiality Disclosure Agreements.
• Corporate Administration: Advice and assistance on various corporate administration matters involving local affiliates and representative offices in the region.
• Other Administrative Matters: Manage External Counsel (i.e. ensure outside counsel retention is managed effectively, that all queries are managed or supervised by legal, etc.); budget: monitor costs vs. estimates; proper invoicing

Compliance

The incumbent will primarily be responsible for the establishment and ongoing maintenance of compliance controls, and for acting as first-line compliance support to the Cluster for healthcare compliance and business conduct matters related (but not limited) to the following:

• Working with Healthcare Practitioners, Healthcare Organizations and Other Decision Makers
• Interactions with Patients and Patient Organizations
• Printed and Published Materials
• Sponsorships, Grants and Donations
• Financial Transparency Reporting

As an integral part of the Group Compliance Network, this role will also partner with the International Compliance Team to implement centrally-driven compliance initiatives and contribute to shaping an evolving compliance framework for the broader business.

• Inform, educate and advise the business on relevant requirements for assigned compliance areas
• Drive the development and maintenance of procedures and policies to support the KKI compliance framework
• Ensure that all staff are provided with the appropriate ongoing training to ensure compliance with both the national, regional and international requirements and relevant policies and procedures
• Ensure that transparency obligations are met and publish all transfers of value in the timeframes required by local laws or regulation
• Investigate breaches of internal and external rules and regulations
• Ensure appropriate monitoring of compliance controls is in place and oversee corrective actions as required
• Ensure that all relevant materials and activities developed in the Cluster are aligned with Kyowa Kirin International policies, guidelines and procedures and the laws, regulations and Industry Code(s) that are applicable in the Cluster.
• Act as a signatory for certain materials and activities, as required.
• Manage Code complaints.
• Monitor the adherence of activities with internal and external requirements, and address emerging issues in a timely and thorough manner.
• Implement the corporate/regional risk management program, in particular with regards to interactions with Third Parties, to ensure optimised protection of KK interests.
• Facilitate internal audits.
• Promote ethical culture.

 QUALIFICATIONS:

• Law degree from recognized university law faculty.
• Full qualification to practice law in at least one jurisdiction.
• Minimum 7 years of law practice, in a law firm (life sciences/health care experience preferred) or in-house in a multinational biopharmaceutical company, or a combination of both. Broad exposure to a variety of   legal areas affecting life sciences companies highly preferred.
• Familiarity with legal systems of one or more GCC countries.
• Experience in a combined Legal & Compliance leadership role is a plus.
• Broad exposure to business development transactions.
• Fluency in English and an excellent Arabic speaker.
• Good personal and communications skills, judgment, flexibility, organizational skills, team player.
• Unquestioned integrity and ethics in business and personal conduct.
• Ability to diagnose legal problems, and present positive creative solutions and alternatives to Management.
• Demonstrated ability to cost effectively manage and direct the activities of outside counsel.
• Strong analytical skills and demonstrated ability to understand complex legal concepts and translate those to non-lawyers to create practical processes, guidance and training.
• Strong project management skills with attention to detail and accuracy.
• In a matrix environment, ability to effectively collaborate with partners across division (teamwork).
• Demonstrated ability to work in a fast-paced, growth-oriented global or regional organization.
• Comfortable with ambiguity.
• Ability to work through challenging situations.
• Strong prioritization and decision-making skills.
• Ability to engage effectively with Cluster Leadership team, to agree on business strategies and initiatives.
• Proactive in staying up-to-date with local legislation and pharma codes and keeping local Leadership Team apprised of significant legal, compliance and corporate developments and trends related to Company business.