Regulatory Policy and Intelligence Manager at Roche

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.

go to method of application »

About EpiCX 

EpiCX is an integrated suite of foundational technologies that enables affiliates to have access to more data, generate richer  customer insight, and design and deliver more personalised customer interactions. Our ability to connect meaningfully with  customers today and tomorrow is critical in delivering on our North star and Pharma vision. 

Concerning IT ambitions, the key factors for the program are the reduction of complexity of our global commercial solution  landscape and replacing many legacy solutions with state-of-art technologies formed as one ecosystem and resulting in a “single  source of truth” approach for many systems globally.

Role & Job Description

In this role, the individual will own and manage data governance function centering around the MDM domains Customer and Product. Individual in this role will partner with business stakeholders primarily and also with IT architecture and system owners to build governance processes including but not limited to data privacy, reference data management, data dictionary, data encyclopedia, business glossary, data cataloging.

Responsibilities

• Own & manage master data assets pertaining to customer and product domains, in a global setting.
• Own and act as the SME on Data Stewardship, Governance & Reference Data.
• Build enterprise wide data governance framework, with a focus on improvement of data quality and the protection of sensitive data through modifications to organizational policies and standards, principles, governance metrics, processes, related tools and data architecture
• Facilitate the development and implementation of data quality standards, data protection standards and adoption requirements across the enterprise
• Establish & oversee data stewardship & data governance processes, collaborating with specified stakeholders and organizations units.
• Oversee relevant work and deliverables coordinating with assigned internal resources and external consultants (onshore/offshore).
• Ensure adherence to various regulations like CCPA, GDPR and other Data Privacy regulations applicable to the organization and our industry.
• Manage & maintain stakeholder relationships in a cross functional environment relevant to the DG function.
• Create and own the budget and ensure that the assigned projects are executed within the planned budget.

Requirements

• A Bachelor’s degree or equivalent.
• Minimum of 8-10 years of experience of structuring & managing data governance function.
• Minimum of 6+ years of experience in commercial / medical Pharma - biotechnology industry.
• Strong knowledge of industry leading data governance, data quality and data protection management practices
• Strong knowledge on data governance practices, business and technology issues related to management of enterprise information assets and approaches related to data protection
• Knowledge of data related government regulatory requirements and emerging trends and issues
• Very proficient in all functions related to data governance applicable to life sciences industry, centered around commercial and medical function.
• Hands on Data Stewardship experience commercial / medical life sciences domain.
• Good exposure to industry standard data governance framework 
• Prior work experience on technology platforms like Collbra will be a plus
• Extreme Proficiency in data privacy regulations like CCPA, GDPR, HIPAA etc.
• Experience in leading cross functional teams on various projects and processes.
• Experience working in a matrix organization leading resources within organization as well as external consultants - onshore/offshore.
• Strong working knowledge of industry standard MDM solutions like Reltio, Informatica etc, relevant to global life sciences industry
• Excellent interpersonal communication skills (verbal and written), be proactive, self-initiator and collaborating attitude

* This position is location agnostic *

go to method of application »

As Talent Acquisition Partner you will play a pivotal role in ensuring we are hiring the best talent to meet our business ambitions. Make Your Mark. Improve Lives. 

We have a fantastic and challenging opportunity to fully combine your recruiting and consulting skills to seek, attract and bring in the very best talent into Roche. This with the focus to support the significant demand for talent within our Roche Europe region, now, and in the future.

As Talent Acquisition Partner you will be part of the Roche EEEMEA Recruiting team, a group of highly skilled professionals in our Integrated Workforce Strategies organization.

The geographic focus will be Czech speaking locations, however you will also be collaborating closely within the Region Europe/EEEMEA, and also within our global network.

MAIN ACCOUNTABILITIES 

In this highly strategic and challenging role your focus will be on the following core activities and responsibilities:

• Be a professional & consultative partner for our business leaders regarding all talent acquisition aspects.
• Provide broad, holistic & customized talent acquisition strategies and solutions, including candidate sourcing & pipelining, talent marketing, talent selection, candidate experience.
• Expertly drive end-to-end global standardized recruiting process.
• Facilitate the decision making process with the hiring manager and the other involved stakeholders to hire the best candidate for the role. 
• Manage the offer process with all necessary stakeholders (creates an offer proposal, obtains approvals, extends offers, and negotiates with the candidate if required).
• At the most senior level, may lead complex recruitment transformation projects across functions at a global level, with close connection to People Relations, Business Partnering and other specialists. 
• Keep up with new talent acquisition trends to drive our continuous improvement.

YOUR PROFILE 

To be successful in this role, you have extensive knowledge and experience as a Talent Acquisition Partner with proven success for example as a recruiter or headhunter. Alternatively you are working in the Life Science/Tech industry and have a strong passion for People & Culture, particularly for Talent Acquisition. 

You have expertise in building and maintaining relationships with stakeholders on all hierarchical levels. You are well-versed in talent attraction, sourcing, and assessing. In addition you have excellent coaching and advising skills, and thus are a trusted partner to your business clients and enable them in their hiring decisions.

First class communication and interpersonal skills are a must as you network and build long term relationships with both internal and external individuals, often at a very senior level. You must be able to work under pressure, and to meet targets in a fast moving environment. You have high influential skills and are an excellent negotiator. Ability to work effectively within international and cross-divisional teams is one of your assets.  You thrive in a dynamic, self-organized environment, love taking on new challenges, and drive innovation. 

Furthermore, you possess the following experiences and competencies:

• Business fluent English and Czech language skills are required; additional European language skills are an extra advantage, but not required
• Work experience in a multinational matrix organisation is an asset
• Works autonomously, and has the dexterity to participate or lead recruiting squads across regions or globally when necessary.
• Diligent user and expert of applicant tracking and sourcing tools such as Workday, Phenom People, LinkedIn 

The position will be based in Africa, the Middle East or any Extended Eastern Europe country. Working-from-Home is enabled; willingness to be present at the site when needed and for occasional business trips is needed. Because of our highly virtual way of working, the need for business travels will be very low.