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JOB PURPOSE

The Africa Partner Markets Regulatory Lead will:

• manage and coordinate the regulatory activities in the G2 Norwest Africa markets.

• ensure the regulatory compliance and data needs including regulatory quality compliance, regulatory database updates and maintenance, etc.

• support the portfolio approach for Science value creation ensuring clear priorities are defined and delivered within the areas of responsibilities.

• ensure the vision for the country activities are delivered within timelines agreed.

• Lead the oversight on the G2 Norwest Africa Partners.

KEY RESULTS/ACCOUNTABILITIES

Examples of Regulatory Activities:

• Ensuring compliance of the existing CHC portfolio, effective and timely approval of all marketing authorizations, maintenance, provide appropriate input on the development of new products and shape the regulatory environment in the markets in scope through close collaboration and interaction with the Partner/s.

• Ensure advice and input is provided to local business strategies with regards to regulatory feasibility, requirements, and timelines.

• Ensure high quality submissions within timelines agreed with Science counterparts, business and/or health authorities

• Foster an environment/culture of learning and sharing of best practice within the team.

• Optimize on cross-functional support within the organization, ensuring effective communication with Science counterparts, key stakeholders like marketing and business teams to deliver on all priorities.

• Foster a close and collaborative relationship with the Partners with regular updates on submissions and regulatory strategic plans.

Examples of regulatory compliance activities:

• Ensure product packaging and associated information are updated, timely implemented and maintained in accordance with the current product licenses.

• Ensure that Marketing Authorizations are updated in line with Company Core Safety Information according to Corporate requirements

• Ensure compliance and training to all mandatory SOPs is completed

• Ensure quality and compliance of local regulatory activities in line with corporate policies, national regulations. Ensure maintenance of regulatory databases.

• Work closely with the Partner to actively follow the development and emergence of new regulatory requirements and assess their impact on the existing products and in development.

• Review and approve promotional and non-promotional materials ensuring their compliance with local regulations, code of conduct and internal guidelines. Coordinate review with the responsible functions in the country. Ensures consistency and conformity to the various published guidelines – Opella., Legislation, and Industry code, as applicable.

• Liaison with local manufacturing facility & the partner in connection with all aspects that affect the dossier held by the relevant Regulatory Authorities.

Examples of Health Authority Interactions activities:

• Support the Partner on any company and local regulatory authorities’ inspections.

• Build good relationship (directly or via the Partner), making Opella. a recognized partner with the agencies

• Develop and facilitate relations with key regulatory authorities and decision-makers at a market level when relevant; discuss and challenge issues and negotiate solutions in the best interests of the company, in partnership with the Partner.

Examples of Regulatory Environment influence activities

• In markets where applicable, support the Partner in shaping the Regulatory environment through active contribution in Zone industry associations and in collaboration with Public & Government Affairs

Examples of Portfolio Management activities:

• Support the management of the local maintenance activities and ensure compliance of the marketed product portfolio in the countries in scope.

• Support development of the Local Regulatory strategies for geographical extensions

• Manage the preparation of local dossiers for the products under development and territory extensions in collaboration with the Partner

• Support development of local strategies and preparation of local OTC switches

• Ensure that best efforts are provided to get timely approvals of dossiers and all risk mitigation plans are in place to avoid any undue risk to business, in partnership with relevant stakeholders.

Examples of Drug Development activities:

• Give Input to Global teams for drug development with regards to local needs (labelling, clinical trials), with support from the Partner, when relevant

Examples Risk Management activities:

• Co-ordinate the local health authority approval and implementation of risk management plans and educational material, in strong collaboration with the Partner

• Ensure public availability of current approved product information for risk minimization (SmPC, educational material, PIL, compendia) is done when relevant

Examples of Portfolio Optimization activities:

• Provide RA input to product portfolio optimization and product pruning and give RA input to global product portfolio optimization strategies and constantly and proactively engage with Has through the Partner when relevant

Examples of Regulatory Database Management activities:

• Lead the compliance of the regulatory registration database.

• Ensure regular tracking and closure of submissions in global databases.

KEY WORKING RELATIONSHIPS

Science stakeholders, Business, marketing, external partners

SKILLS, EXPERIENCE & KNOWLEDGE REQUIREMENTS

Education

• Degree in Pharmacy or Science Degree or relevant Academic qualification is desirable.

• Current and valid certification in line with the local regulations, an advantage.

Required knowledge and/or experience

• Extensive experience in Regulatory Affairs, with a minimum of 5 years’ experience

• Working experience in the French Africa Zone particularly in a North African area.

• Good understanding of the consumer healthcare and pharmaceutical industry, drug development environment, and R&D processes and objectives

• Knowledge of the local Consumer Health environment (regulatory, Zoneal Industry Associations, Public & Government affairs).

• Demonstrated success in partnering and influencing across a matrix environment with exceptional executive communication skills

Language skills

• Fluent spoken and written French and English (mandatory)

• An Additional language is desirable

Cultural traits

• Push to go beyond the level we have operated until now :constantly challenge the status quo focusing on the priorities that will deliver the best outcomes and letting go what won’t: be intolerant to mediocracy, believe we can and must do better and aim at higher but never at the expenses of our values and judgment

• Put the interest of the organization ahead of own of those of his her team :consider both short and long term impact of decisions ; puts collective and global goals above individual or local goals; share resources and capabilities with those with the greatest need and impact; enable decision making at appropriate level

• Act in the interest of our patients and customers:actively engage with customers to know their current and future needs; brings an external perspective into decisions

• Take action and don’t wait to be told what to do:take smart and informed best bets with the information at hand and anticipate the consequences of her/his actions; use personal judgement and others’ advice to make bold and impactful decisions which move us forward

• Role model our 4 values: teamwork, integrity, respect, courage

Required Leadership Competencies

• Strategic Thinking - ability to evaluate relevant areas of operation, formulate objectives and set priorities in a contextually relevant way, and develop plans consistent with long-term organizational interests

• Business Acumen – Ability to effectively use economic, financial, market, stakeholder, and industry-specific indicators to fully understand and improve business results

• Judgement- The ability to draw logical conclusions based on acquired information and analytical rigor in problem-solving, the ability to make effective decisions even when information is ambiguous or incomplete

• Team Leadership – Ability to build cohesive, high-performance teams that take accountability and achieve required results

• Interpersonal relationships - treating others with courtesy, sensitivity, and respect.

• Change Leadership - The ability to demonstrate support and drive for innovation and organizational transformation

• Personal Leadership - Personal leadership translates into courage, choice, and commitment through the pursuit of excellence, trust, and accountability. Ability to put patient, stakeholder, and organizational interests above personal interests

• Drive -Takes the lead and initiates activities with a high degree of passion and commitment as well as the drive, desire and need to achieve challenging goals, to improve performance or to meet personal standards of excellence

• Learning Agility – Ability to navigate first time/unfamiliar situations effectively by extrapolating from other areas of expertise and knowledge. Ability to continuously improve and develop self.

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