Jazz Pharmaceuticals, Inc. Associate Director Promotional Regulatory Affairs in Oxford, United Kingdom
Associate Director Promotional Regulatory Affairs
Regulatory Affairs (G & A)
Oxford, United Kingdom
Associate Director, Promotional Regulatory Affairs, EU/ROW serves as an internal expert on European (EFPIA) and International (ex-US) regulations governing the promotion of prescription pharmaceutical products. The associate director will provide regulatory oversight/ leadership to this key business process; providing strategic direction and regulatory review for commercial activities for the EU/ROW markets; interacting with Health Authorities and assisting with managing responses to inquiries if required. In this position, the associate director will work collaboratively with the EU/ROW Medical, Legal, Compliance and Commercial organizations and apply expertise and organizational influence to insure development of promotional programs and tactics that are compliant with regulations, relevant codes of conduct and company policies, while supporting achievement of business objectives. Reporting to the Head of EU/RoW Promotional Regulatory Affairs and Labeling, this position must be capable of representing the commercial regulatory perspective and applying expertise and organizational influence with cross functional teams.The role is responsible for operating an EU/ROW. advertising and promotion Center of Expertise, determining work processes and resource needs, and must be knowledgeable in applying the IFPMA, ABPI, EFPIA codes of conduct and build a network to ensure adherence to local country regulations and codes of conduct for markets where our products are marketed.Essential Functions
Accountable for maintaining a process and establishing standards to ensure that promotion for products in markets supported comply with company policies and SOPs, while maintaining consistency across markets in the core promotional efficacy claims and risk information.
Support EU/ROW marketing and medical teams by participating in strategy discussions and extended team meetings. Provide regulatory strategy, guidance, and consultation on marketing strategies and promotion objectives and tactics as well as medical education tactics. Lead and own the promotional material review process and make decisions regarding concepts and draft promotional materials to satisfy the letter and spirit of applicable EFPIA/International promotional regulations, corporate standards and policies and business objectives. Take responsibility for the review and approval of International Promotional materials from a regulatory perspective.
Support regional and local employees by developing a network of regulatory and medical contacts, acting as consultant in regulatory and compliance matters, supporting local employees in promotional complaints, and determining the training needs for International stakeholders.
Support development of and adherence to company policies, processes and standards for promotional compliance and participate in the revision, update and approval of EU/ROW SOPs, policies and associated materials, including the development, integration and update of local processes and standards for promotional material review.
Provide input on promotional implications of proposed clinical study designs, draft publications, commercial campains and compliance issues
Maintain a deep and current awareness of evolving regulations, codes of practice and policy issues affecting the pharmaceutical/biologics industry in relation to advertising and promotion. Interpret and communicate health authority perspectives to relevant stakeholders and recommend policy and/or procress changes as needed.
Work to find solutions to promotional material review challenges and implement process enhancements as needed.
Bachelor degree minimum, Masters, or other advanced degree in a scientific discipline preferred
Minimum of 8 years of increasingly responsible experience in the pharmaceutical industry, including at least 5 years of direct experience in advertising and promotional material review
Extensive experience and knowledge in the Advertising & Promotion field, including superior working knowledge of IFPMA, EFPIA, and ABPI related advertising codes
Strong judgment and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies; demonstrated ability to take a big-picture approach to decision making while taking account of the interests of the entire company.
Outstanding verbal and written communication skills.
Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.