Shire US Regulatory Affairs Lead, Advertising & Promotion in Lexington, Massachusetts
The US Lead for Regulatory Affairs, Advertising and Promotion (A&P) serves as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. The role is responsible for thoroughly reviewing and assessing proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements and Shire policies. The Lead will be responsible to develop, integrate, implement, and ensure compliance with the US CMLR process and US CMLR Standards. Works collaboratively with colleagues in Regulatory Affairs, Medical, Legal, Commercial, and Compliance organizations and applies expertise to ensure promotional and non-promotional material development is accomplished following Shire US CMLR process and standards. Establishes and maintains favorable interactions with FDA.
May provide direct supervision of individuals including mentoring, performance management, and staffing decisions.
% of Time
Job Function and Description
Provides expert regulatory evaluation of proposed promotional and disease state materials for assigned products. Evaluates materials to ensure compliance with FDA regulations, guidance, corporate standards and policies, and business objectives. In collaboration with Commercial, Medical and Legal colleagues, conducts a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims, and assesses consistency of proposed claims with FDA-approved labeling. Serves as the chair of CMLR meetings, and assists Commercial with the planning and prioritization of proposed promotional and disease state materials. Provides expert guidance related to Regulatory strategy during early development projects to ensure promotional goals can be achieved.
Ensures consistent review standards within the EAS system are upheld, and business needs are assessed and addressed. Works collaboratively with colleagues in A&P, Medical, Legal, Commercial, and Compliance to achieve alignment. Provides consistent, well-supported, and clear guidance to key stakeholders.
Supports metrics to measure and track the effectiveness and efficiency of the CMLR process, provides recommendations for process improvements to address issues, gains agreement of process improvements from key CMLR-stakeholders, and implements agreed upon process improvements.
Collaborates with the International A&P review teams for materials that are intended for global audiences.
Maintains a thorough understanding of OPDP and/or APLB requirements, as well as a keen awareness of enforcement trends. Participates in the preparation and review of comments to FDA’s docket regarding Federal Register Notices that may impact the organization’s promotion of commercial products.
Serves as primary liaison with OPDP and/or APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products.
Education and Experience Requirements
Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
Ideal candidate has a minimum of 5 years’ experience in drug, biologic and/or device Regulatory Affairs or related field, including a minimum of 2 years’ experience specific to Regulatory Affairs – Advertising and Promotion. Candidates with experience in related fields may also be considered.
Demonstrated knowledge of regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products.
Key Skills, Abilities, and Competencies
Expert understanding of FDA regulations and guidance regarding advertising and promotion of prescription drug and biologic products
Excellent verbal and written communication skills
Demonstrated interpersonal skills with ability to demonstrate strategic and analytical thinking
Ability to work successfully with a cross-functional team
Ability to work independently, take initiative, and complete tasks to deadlines
Must be able to work in a fast-paced environment with demonstrated ability to juggle multiple competing tasks and demands
Listens to and carefully considers others’ perspectives, especially to manage and resolve conflict
Drives accountability and responsibility that enables others to act with integrity
Complexity and Problem Solving
Works with the VP Global A&P, A&P Senior Directors, leaders within A&P, and business partners to identify and resolve issues regarding the acceptability of promotional and disease state programs and tactics. Works with CMLR teams to maintain regulatory compliance while helping to meet commercial objectives. Support metrics to measure effectiveness of the EAS system, CMLR process, develop recommendations for process improvements, gain endorsement for recommendations, and implement accordingly. Regularly required to exercise good judgment and work effectively in ambiguous areas.
Internal and External Contacts
Internal stakeholders include Commercial, Commercial Operations, Regulatory A&P, Regulatory Affairs, Legal, Medical, Compliance, and Sales Training. External contacts include third-party Commercial Agencies and FDA/OPDP/APLB.
Other Job Requirements
Expected travel: 15%
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf
Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.