Regulatory Policy and Intelligence Manager at Roche Kenya

Roche in Nairobi is seeking a skilled leader to fill the position of Regulatory Policy and Intelligence Manager for Diagnostics to build and maintain a highly collaborative function for gathering and communicating regulatory intelligence, identifying and analysing changes in the regulatory environment, collaborating with Global Regulatory Policy & Intelligence to adapt global Roche Diagnostics’ regulatory policy positions to Africa and creating and executing strategic advocacy plans to achieve Roche Diagnostics’ regulatory policy goals.  The position provides oversight and direction, and works collaboratively with stakeholders and subject matter experts, to influence the policy environment established by African regulatory authorities. The role entails leading and managing the Regulatory Intelligence management process for the Diagnostics Management Centre.

Key Responsibilities

Development of Policy Strategy

• Provision of oversight and direction to the Diagnostics Management centre on regulatory policy, strategy, and influencing efforts such that Roche Diagnostics is recognized as an industry leader with health authorities and industry peer groups.
• Overseeing the development and maintenance of a current picture of regulatory policy in Africa, including analysis of processes and issues, their impact on Roche Diagnostics, and the pathways for influencing such policy.

RPI Processes

• Leading and directing an active regulatory intelligence function that gathers, analyses and communicates up-to-date information regarding regulatory policy activities and trends for Africa.  Working with global RPI to ensure timely identification and reporting of regulatory intelligence to the Business and Global Functions.  Ensuring the notification of final changes consistent with Global Standard Processes.
• Ensuring effective internal processes for selecting and prioritizing issues on which Roche Diagnostics will focus its regulatory policy and advocacy efforts.  Partners with subject matter experts and internal stakeholders to evaluate and develop positions and advocacy plans regarding proposed laws, regulations, guidance, policies and standards issued by national and/or regional regulators.

Relationship Management

• Managing responses to proposed laws, regulations, guidance and standards submitted directly by Roche Diagnostics, as well as through industry organizations and coalitions.  Collaborating with global RPI as needed to ensure consistent messaging and positioning.
• Partnering with external stakeholders and allies, as appropriate, to build alignment with Roche Diagnostics’ regulatory policy positions and encourage external advocacy efforts consistent with those positions.  (e.g., non-profit associations, industry organizations, think tanks, coalitions)
• Fostering relationships based on trust and respect with key health authorities, and facilitates engagement with regulators on key topics of interest to Roche Diagnostics.  Seeks to establish Roche Diagnostics as a trusted partner with health authorities.

Internal Collaboration

• Collaborate closely with Government Affairs and other key stakeholders within Roche Diagnostics to ensure alignment on regulatory policy goals, policy positions, and advocacy efforts, as well as a consistent approach across regulatory, administrative and legislative arenas.
• Serve as a key point of contact on Roche Diagnostics’ regulatory policy matters in Africa, and as representative at industry and coalition meetings related to regulatory policy and advocacy in Africa.

Communications

• Communicate specific regulatory and quality trends, analysis and intelligence to global RPI and collaborate with Global RPI to communicate with Quality and Regulatory staff and Roche Diagnostics’ Leadership, as needed.
• Partner with Q&R and subject matter experts to facilitate implementation of changes to Roche Diagnostics Divisional Standards, policies, procedures or practices based upon changes in the regulatory environment.

Training

• Provide training and support for Q&R teams and others as needed, on key regulatory policy issues, directional changes in regulation, and trends in the regulatory environment.
• Provide training to build capacity across Africa for influencing the regulatory environment.
• Continuous improvement
• Monitor and develop measures to determine the impact of Roche Diagnostics’ regulatory policy strategies.

You, as an ideal candidate, will have the following skills, experience and education:

• Qualifications: Advanced Degree, preferably in Pharmacy.
• Experience: At least 10 years regulatory experience in the diagnostics/medical device industry, with demonstrated expertise in the areas of regulatory policy, advocacy and intelligence.
• Other requirements: Subject matter expert in regulatory processes, laws and regulations, with a strong understanding of both the informal and formal aspects of how regulatory policy is shaped and developed, thorough knowledge of Africa regulatory including Health Authorities, Health Authorities staff and Health Authorities policies; complete understanding of the Africa Health Authorities Acts and associated regulations and guidance, proven ability to develop innovative regulatory strategies and key positions on regulatory policy topics of interest.

A full job description will be provided to candidates attending an interview.