Job Description

• Develop and manage the Regulatory Affairs Managers within the assigned affiliates through regular updates, performance reviews and development plan discussions.Be accountable for the day to day management of the Regulatory Affairs Managers within assigned affiliates.Manage competing regulatory, compliance and commercial priorities in partnership with the local General Manager/Medical Director in assigned affiliates.
• Support Regulatory Affairs personnel in the assigned affiliates through ongoing communication, assisting in the development, training and mentoring of regulatory leaders (i.e. Regional Meetings among others). This includes support for the development and execution of local regulatory strategies (such as key filings, within the agreed upon timelines).Be responsible for performance management of the team and to develop the team to be senior leaders within the organization.
• Assess the training needs of the Regulatory Affairs Managers and other members of the Regulatory Affairs Teams in the assigned affiliates.Mentor the Regulatory Affairs Managers in the assigned affiliates with respect to technical and leadership capabilities.
• Provide training to Area and Affiliate Regulatory Affairs personnel on AbbVie policies and procedures.Management of Regulatory budgets within the assigned affiliates.Develop, review and maintain Global and Area processes.
• Effectively prioritize resources within the assigned affiliates and follow up to assure success. Establish an effective and collaborative working relationship with the local General Manager/Medical Directors in the assigned affiliates to ensure local business needs are met, resolve any competing priority conflicts and include feedback in performance reviews and succession planning.
• Oversee the Regulatory Affairs budgets for the assigned affiliates and monitor adherence to the budget throughout the financial year.Ensure regulatory compliance within the assigned affiliates with global processes, such as the monthly labeling compliance report, and local requirements, such as timely notification to Area of local renewal requirements. Implement remediation plan to address identified gaps, if any.
• Lead implementation and maintenance of processes and systems across Region.Review implementation of global processes and / or select initiatives within the Area Team and suggest improvements to current processes and develop new Area processes, as required in close collaboration with the Head of Project Management for A&A.
• Maintain an active awareness of the legislative environment in the assigned countries and assess the impact of any changes on AbbVie business. Communicate any changes within the Area RA Team and the Regulatory Intelligence group.Develop and maintain Area databases of regulatory knowledge, (such as individual country data requirements, time to approval in Regulatory Agencies within the Area, fees payable for all types of regulatory submissions).
• Support Long Range Planning and Future Fit initiatives in assigned affiliates.Provide regulatory counsel on select business development activities for the Area.
• To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie. To identify resource needs and priorities within business priorities.

• 10 years’ pharmaceutical industry experience in Regulatory Affairs or R& D, with minimum of 8 years’ experience in Regulatory Affairs. At least 5 years’ extensive Area regulatory experience.
• Experience working effectively across cultures and in complex matrixed environment.
• Experience of managing remote groups in multiple locations.
• Experience of managing Regulatory groups to budget.Excellent verbal and written communication style at all levels.
• Strong leadership presence and solution-driven leadership style.Ability to work independently with minimal supervision.
• Strong interpersonal, managerial and organisational skills.Understands business needs and impact of regulatory issues on these.
• Management of 4 – 10 Regulatory Affairs Managers in assigned affiliates.Percent of Travel: 30% at least.
• Sensitivity to Area culture and ways of doing business.
• Bachelor’s degree in pharmacy, biology, chemistry, pharmacology or related life sciences subject is required. Graduate degree preferred.