*company description*
*job description* purpose*:
to oversee and manage the regulatory strategy and compliance efforts for the affiliate.
ensures that all products meet the necessary regulatory requirements throughout their lifecycle, including development, approval, and post-marketing stages.
the director is responsible for liaising with regulatory agencies to facilitate approvals, maintain licenses, and ensure that all regulatory submissions are complete, accurate, and timely.
identifies resource needs and tasks aligned with the business priorities.
leads the regulatory affairs organization in assigned affiliates additionally, is the primary regulatory affairs interface with local leadership teams with cross-functional teams.
accountable to integrate regulatory considerations into commercialization plans, ultimately supporting the company's business objectives while maintaining compliance with applicable laws and regulations.
*responsibilities*:
- leads the development and implementation of the regulatory strategies and tactical plans for appointed affiliate.
- anticipates the evolving regulatory environment to identify, prioritize and mitigate current and future regulatory risks.
ensures regulatory compliance while maximizing product potential (benefit/risk) in alignment with business strategies.
the incumbent must translate business needs into clear regulatory strategy objectives including development of region/area-based regulatory strategies and deliverables that are meaningful and easily understood by region/area-based commercial staff.
- works across all therapeutic areas (in development and marketed products) for abbvie's portfolio and influences the development of regulations and guidance.
ensures management is aware of the effect of current, newly finalized or proposed laws, regulations, guidelines and standards.
- maintain an active awareness of the legislative environment in the assigned country(ies) and assess the impact of any changes on abbvie business.
communicate any changes to the affiliate management team (amt), area ra team, and the regulatory intelligence group.
develop and maintain databases of regulatory knowledge, (such as individual country data requirements, time to approval in regulatory agencies within the affiliate, fees payable for all types of regulatory submissions, etc.).
- develops, leads and manages the regulatory affairs managers within the assigned affiliate through regular updates, performance reviews and development plan discussions.
supports all of the regulatory affairs personnel in the assigned affiliate through ongoing communication, assisting in the development, training, and mentoring of regulatory leaders.
- assesses the training needs of the regulatory affairs managers and other members of the regulatory affairs teams in the assigned affiliate.
mentors the regulatory affairs managers in the assigned affiliate with respect to technical and leadership capabilities.
- manages competing regulatory, compliance and commercial priorities in partnership with the local general manager and amt in assigned affiliate.
- understands and articulates a deep affiliate-based perspective across the pharmaceutical and aesthetics business/regulatory systems and the impact on all products, markets, and compound opportunities in the assigned region.
- primary interface between the regulatory affairs team and amt.
establishes an effective and collaborative working relationship with the local general manager and amt 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, and other local requirements, including timely notification to area of local regulatory requirements.
implement remediation plan to address identified gaps, if any.
- forecasts future departmental needs including human and material resources and capital expenditures.
actively participates in leadership meetings, providing regulatory and management expertise and decision-making.
- lead implementation and maintenance of processes and systems across affiliate.
review implementation of global processes and / or select initiatives within the affiliate.
develop, review and maintain affiliate processes in line with global and area processes.
- support long range planning and future fit initiatives in assigned affiliate.
provide regulatory counsel on select business development activities for the area.
*qualifications*
qualifications:
- 10 years pharmaceutical industry experience in regulatory affairs.
at least 5 years extensive affiliate regulatory experience.
- strong understanding of the local regulatory environment, including extensive experience in interacting with the heal