JOB SUMMARY

• The PCO Regulatory Sciences Manager would represent Regulatory at Plan of Action meetings 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.

JOB 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, and 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 achieving 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. The face before the MOH authorities.
• Active participation in trade organization of the 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 an assessment of the impact on 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.

QUALIFICATIONS / SKILLS

Qualifications:

• Science or Pharmacy Degree or A higher degree (MS or Ph.D.) may be an advantage but is not essential.
• Appropriate Regulatory Experience minimum 5 years of 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 in effective delivery in a complex matrix environment.

Skills:

• 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.