The Head of Regulatory Affairs provides regulatory vision and leadership to the Affiliate. S/he executes these responsibilities by utilizing experience, knowledge of regulatory landscape, passion and creativity to provide patient-centric and compliant regulatory expertise in line with AbbVie’s vision.

S/he supports the best interests of patients, the Affiliate and AbbVie within the country with regard to interactions with the regulatory agency and other regulatory authorities.

Within AbbVie s/he represents the country to the wider organization throughout the product lifecycle. S/he contributes to the affiliate's overall success by developing objectives, strategies and tactics in line with business goals and culture. S/he is an active participant in the business life of the affiliate leading and supporting affiliate initiatives.

Overall responsible for all regulatory affairs activities within the AbbVie Ireland commercial affiliate and Malta. Accountable for the development and execution of regulatory strategy, tactics and timelines.

As member of the affiliate management team collaborates actively to create a vision, strategy and objectives for the company’s product portfolio (medicines and devices) and initiatives, and transmits the vision and objectives to the affiliate regulatory department. Supports the business of the company including involvement in planning for and execution of product launches, acquisitions and divestitures.

Develops and manages the RA department to ensure optimal function of the department, development of strategic and tactical plans and execution. Supports the affiliate RA team to:

• Work with the affiliate brand teams to provide regulatory information on affiliate products and to develop strategies, objectives, tactics and timelines for those products throughout their lifecycle
• Work with the area regulatory team to advocate for the affiliate's strategy objectives and timelines
• Work with local regulatory authorities to obtain optimal outcomes for patients and Abbvie’s portfolio

Ensures appropriate and timely communication of regulatory information within the regulatory department, to pharmacovigilance and other internal stakeholders, as well as to the authorities, as required by local regulation, company policies and procedures.

Responsible for the Irish Regulatory budget and participate in affiliate and function budget, long range and NNLRP exercises, monitor and update budget and manage resources in compliance with the budget and planning exercises. 

Ensures compliance within the regulatory department and collaborates with pharmacovigilance and other stakeholders, as appropriate, to ensure compliance with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie. Overall responsibility for affiliate compliance with focus on (but not limited to):

• Ensure adequate staff qualification and training
• Act as primary point of contact for RA audits and inspections in Ireland, if appropriate
• Ensure submission and content of new Marketing Authorisations, variations and other regulatory submissions, including label, artwork and local prescribing information. Manage the tracking of the implementation of MA variations (safety) and HPRA regulatory commitments.
• Ensure Promotional, non-promotional and training materials are compliant with local regulations and internal policies and procedures
• Cover regulatory aspects of Pharmacovigilance as applicable

Provides effective resolution of regulatory issues occurring within the affiliate, with an appreciation of business needs and priorities.

Is present in the country regulatory environment including interactions with regulatory policy makers and professional associations in order to gather knowledge about trends, future changes and current landscape in accordance with the national and EU legislation and relevant Associations’ Codes. Oversees the analysis of evolution of Ireland and European pharmaceutical law and its consequences for the company’s business, processes and/or procedures.

Liaises with local regulatory authorities and appropriate legislative bodies and industry associations as required. Build a relationship with the HPRA and be the central point of contact for all AbbVie Ireland regulatory affairs activities where relevant.

Works in consultation with AbbVie European and Global regulatory colleagues to ensure that all Irish affiliate, Health Products Regulatory Authority (HPRA), and Malta Medicines Authority (MMA) requirements are met.

Liaises with Corporate groups, including European Regulatory Affairs, Global Regulatory Affairs, Market Access, Medical, Patient Relations and QA. Collaborates with other functions of the Management Team to ensure consistency in vision, strategy, tactics and communication with external agencies and stakeholders.

Third level qualifications: Life Science Degree or equivalent.

Advanced experience within regulatory affairs.

Mastery of relevant regulations and ability to stay abreast of pertinent regulations. Knowledge and experience of GDP, GCP and Medical Device regulatory environments would be beneficial.

Ability to build strong relationships with peers and cross functionally and with partners outside of the team and company.

Builds highly effective teams and can motivate and influence others, including those over whom they have no direct authority.

Ability to manage inclusively and equitably across all.

Strong visionary, strategic, tactical, and motivational skills.

Strong negotiation, influencing, presentation skills.

Consultative and collaborative interpersonal style

AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.