133 days ago on shire.com

Associate Director Global Regulatory Affairs - International Advertising And Promotion

Shire International GmbH

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Associate Director Global Regulatory Affairs - International Advertising And Promotion

Posting TitleAssociate Director Global Regulatory Affairs - International Advertising and PromotionEmployee TypeRegularJob Id14566BRLevelASSC DIRFunctionR & DSearch Location(s)Switzerland - ZugJob CategoryCompliance, Regulatory Affairs, Medical Affairs, Medical Communications/Medical information, Marketing/Product Management
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

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.

Primary Duties
The Lead, International Advertising and Promotion, is accountable for the Shire CMLR process which defines the review of promotional and non-promotional materials and is responsible for the development, implementation and integration of the International review standards (ICS).
This role is responsible and accountable for reviewing and assessing Internationally produced promotional and non-promotional items for a designated therapy area or products. This role will provide support for a designated region to develop, in collaboration with the Senior Lead, the strategy and integration and implementation of the Local review process variations, working instructions and assist in local complaint management in order to ensure consistency with the International processes. The IA&P Lead will take on development projects for the support of the International A&P team and the CMLR process.

• Provides expert regulatory review of the internationally developed promotional materials for a designated therapy area or products.
• In liaison with Commercial, Medical and Legal conducts detailed review and evaluation of adequacy of clinical evidence provided to support proposed claims and assesses consistency of proposed claims with the approved prescribing information.
• Takes ownership of the Pre-CMLR meetings to provide expert regulatory guidance, pre-empts areas of concern and evaluates draft promotional materials. Assists marketing, in close collaboration with Medical and Legal, with the planning and prioritization of the review of promotional materials. Provides expert feedback to Regulatory strategy during early development projects to ensure promotional goals can be upheld. Ensures IA&P analysis is provided within the development of the global regulatory strategy plan. Takes ownership and lead the international complaint processes and supports the senior lead for regional complaints.
• Maintains a collaboration tool for interdivision discussion and alignment of review criteria to facilitate consistency and review quality with CMLR review teams within the International business
• Close collaboration with the LOC regulatory contact points and CMLR ambassadors, in order to ensure internationally produced pieces are optimally used at the LOC level.
• Executes the development, integration and update of the LOC processes and standards for promotional review and ensures full training implementation.
• Addresses unmet LOC needs through LOC discussions and the development of online collaboration tools

Education and Experience
• Education Minimum Requirement: B.A. or B.S. degree
• 5 years experience in pharmaceutical/biologics regulatory, legal, scientific, medical, or marketing disciplines
• Experience and Skills - Experience in International CMLR review and approval processes of pharmaceutical/biologics promotion
• Ability to understand EFPIA and International (ex-US) regulations basics for advertising and promotion of prescription products
• Ability to understand of the basics for pharmaceutical promotion development and review processes
• Excellent English verbal and written communication skills