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POSITION : Regulatory Affairs Manager

Position Purpose

The PCO based Regulatory Manager for a country will lead, manage and provide strategic direction to develop and execute regulatory strategies and plans for the country and/or products under his/her responsibility, where applicable.
The PCO Regulatory Manager would represent Regulatory on the Country Manager Forum (CMF) and local Country Medical Council (or equivalent) to ensure collaborative connectivity with these key stakeholders (e.g. Commercial, Medical, etc), and a more focused regulatory approach to supporting country business objectives.
Primary Responsibilities

Lead and manage the development of regulatory strategies to support the registration of clinical trial applications, new products, line extensions, major variations and lifecycle management. Ensure to provide strategic regulatory input into global regulatory strategies, thus providing optimal support for meeting local business objectives.
Develop strong partnerships with in-country teams (e.g. Country Managers, Medical, Marketing, Supply Chain), Regulatory Clusters, Regulatory Regional Teams to facilitate the development and implementation of registration strategies to expedite the registration of new products, line extensions and lifecycle optimization.
Provide strategic contribution to the country (PCO) leadership team– anticipate what Regulatory needs to contribute to achieve business objectives.
Responsible for developing and enhancing relationships with key external agencies (HA’s/BoH, RKOL’s, etc.). Manage the HA/BoH interface throughout the development and lifecycle of a product, developing a long-term and positive relationship characterized by Integrity, Quality, Compliance and Leadership. Face before the MOH authorities
Active participation in trade organization of country and effective communication to key stakeholders of key issues that could impact regulatory strategies or the business. Understand local regulations and developing trends in the local regulatory environment of the countries that support and provide assessment of the impact to key stakeholders. Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies, and decision making. Influence on new sanitary legislation initiatives that could impact the business.
Technical Skill Requirements

Knowledge of the Local regulatory environment and how this impacts regulatory strategy and implementation.
Knowledge of drug development practice, rules, regulations and guidelines.
Communication skills
Negotiation skills
Problem Solving
Understands Pharmaceutical Industry
Understanding stakeholder needs
Network and alliance building/ peer relationships
Influencing
Team working
Interpersonal acumen
Organizational agility
Perspective
Strong quality and compliance orientation
Analytical Thinking
Adaptability
Qualifications

Pharmacist Degree or a higher degree (MS or PhD) may be an advantage but is not essential.
Appropriate Regulatory Experience - minimum 5 years’ experience
Demonstrable experience across the Drug, Discovery, Development and commercialization lifecycle, with proven examples of contribution.
Proven ability to manage complex regulatory issues.
Proven ability to consistently deliver to time, cost and quality standards.
Local regulatory experience including knowledge of CTA’s and NDA submission processes and product life cycle management activities.
Demonstrable experience of effective delivery in a complex matrix environment.

Organizational Relationship(s) including to whom the position reports (JD Job Title):

Direct Report to Head Regulatory Affairs East and West Africa Cluster
Member and strategic contributor to the Country Medical Council and other PCO based teams (new product planning teams, etc.)
Member and strategic contributor to the Country Manager Forum (CMF).

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