Shire Germany Regulatory Affairs Product Lead in Berlin, Germany
The Germany Regulatory Affairs (RA) Product Lead provides regulatory strategy for part of the Shire product portfolio in Germany within the local business/operating company (LOC). Primary responsibilities include operational regulatory affairs activities, involving interface from LOC to European and Global RA, ensuring conformance to national and EU Drug Laws, maintaining labeling information to internal and external partners, communicating with national regulatory authority and regulatory institutions if required in collaboration with EU strategists, supporting internal Global RA, other R&D departments and providing collaborative support for commercial teams. Approval of promotional materials in accordance with German national legislation and codes of practice. Responsibilities include ensuring adherence to company standards and local laws.
NATIONAL REGULATORY AUTHORITY INTERACTIONS (20%)
Be the primary contact with German regulatory health authorities (HA) – Paul-Ehrlich-Institut & BfArM – in national (phase of) procedures and post-approval for the assigned part of German product portfolio, including HA liaison regarding field corrective actions / direct healthcare professional communications, risk minimisation measures or supply constraints.
Develop professional and effective working relationships with national HA.
Support EU regional RA strategists in their HA communication related to European submissions for development/marketed products, in particular where Germany is reference member state or (co)rapporteur.
Facilitate preparation for scientific advice meetings with national agencies
Ensure timely responses to incoming authority requests.
Document and store HA interactions in line with Shire procedures.
In collaboration with Global Drug Safety, proactively assess any risk minimization activities and engage with HA to gain approval of risk minimization measures / educational materials
In cases where clinical trial application (CTA) submission has been agreed to be handled in-house through LOC: May submit local observational study protocols to HA in collaboration with EU RA Strategist and/or may be involved in CTA submissions for Shire-sponsored interventional trials.
COUNTRY RA PRODUCT RESPONSIBILITIES (10%)
Ensure for assigned products the handling of local registration activities, marketing authorization and variation submissions in close collaboration with EU RA Strategy team according to Shire EU RA operating model and local regulations.
Ensure regulatory affairs review and approval of promotional materials
Ensure appropriate RA support for local product launches
Provide regulatory affairs input to Health technology appraisal/ horizon scanning for product portfolio, product tender and pricing application support,
Provide regulatory guidance and make relevant submissions for Early Access Medicines Scheme (EAPs)
Provide regulatory advice to support the German business strategy. Support the DACH RA Cluster Lead in ensuring that German regulatory requirements are fully represented in discussions at global, regional and local levels.
Ensure appropriate contract and oversight is in place with any external partners who support Regulatory Affairs activities for Germany.
May be mentoring more junior colleagues
PRODUCT LABELING IMPLEMENTATION (30%)
Ensure that final product labeling complies with HA approval and Company Core Data Sheet (CCDS)
Provide consolidated feedback from relevant LOC functions regarding text translations to EU Regulatory Strategists & Regulatory Labeling
Request creation of artwork (updates) where required based on national HA approval; review all packaging artworks for assigned products (centralised, MRP and national) for consistency with the marketing authorization and local requirements (e.g. blue box, trademark and design requirements).
Keep internal global labeling repository and external product information compendium (Rote Liste – Fachinfo-Service) timely updated
Liaise with LOC functions to ensure that all product information used is up to date
INFORMATION OFFICER (Informationsbeauftragter – AMG §74a) (30%)
Assume the role of one of the Information Officers according to the provisions of Section 74a of German Drug Law with responsibility, in particular, for ensuring compliance with the prohibition of marketing products which bear misleading names, specifications or presentations and ensuring that the labelling, the package leaflets, the expert information and advertisements correspond with the content of the marketing authorization.
On behalf of the MAH:
Issue and update the abbreviated prescribing information for promotional material (Pflichttext) according to the law on medicinal product advertising (Heilmittelwerbegesetz §4)
Certify (sign off) promotional materials and patient support materials on Shire products according to global Shire procedure, German advertising law (HWG §3, 3a, 4) and applicable codes of practice.
Participate in local review teams and work to local regulations / requirements/codes for the review of local promotional and non-promotional materials,
Provide regulatory affairs advice to LOC team, International Commercial, on maintaining compliance of Shire activities and materials with local regulations/requirements codes at any International symposia/conferences to be held in their country.
Responsible for bringing to the attention of R&D Compliance/Quality Assurance any planned local SOP or local SOP revision, which they are aware of, and which relates to R&D activities
Responsible for immediately notifying R&D Compliance/Quality Assurance of any planned health authority inspection relating to R&D activities and will work with R&D Compliance/Quality Assurance to prepare for the inspection, receive/host the inspection, and respond to findings.
REGULATORY INTELLIGENCE & RA INSPECTION-READINESS (10%)
Proactively monitor applicable local regulations and ensure clear communication of country regulatory requirements to DACH functions and global RA
Monitor the status of competitor marketing authorisations as agreed with the local business
Support permanent inspection-readiness of LOC RA for assigned products in accordance with local regulations and internal standards and policies
Execute timely local implementation and tracking of safety labeling changes
Support the oversight of the local promotional material review process in the cluster, in close collaboration with Country Medical Heads, Compliance Officer and GRA International Ad&Prom team
May participate, in cooperation with superiors and with support of R&D Quality & GRA Process & Standards, the implementation of global/regional Shire SOPs into local RA practice; where necessary, create local SOP addenda in alignment with Region Head
Support as applicable the planning, execution and follow-up of internal audits and HA inspections in conjunction with Quality functions
Education and Experience Requirements
BSc/MSc in Pharmacy or Life Sciences (PhD or PharmD preferred).
Minimum 8 years of experience with multinational companies in regulatory affairs
Proven experience and relationship with German Regulatory Authorities
The necessary expert knowledge and the reliability required to perform the activities as Information Officer as per section 74a of German Drug Law to responsibly fulfil the tasks of providing scientific information on the medicinal products
Key Skills, Abilities, and Competencies
Knowledge of the national and EU pharmaceutical legislation
Understanding of Drug Development and Marketing processes and requirements
Strong scientific background
Proven interpersonal, communication, analytical, and organizational skills
Ability to challenge self and others to overcome barriers and deliver high quality solutions
Strong judgment and decision-making skills with the ability to understand how decisions fit into the broader context of corporate strategies.
Effectively embraces change and is able to flourish in a global structure
Creates an open collaborative environment of continuous improvement within LOC stakeholders and Global functions
Demonstrated ability to assess the internal and external environment to recommend appropriate risk-taking.
Incumbents at this level are involved in a variety of diverse scope and complexity of projects which require strategic thinking and thorough and practical solutions.
Ability to handle multiple tasks and work under pressure;
Consistently exhibits Shire’s Leadership Behaviors and integrates Shire's Code of Ethics into all aspects of business activity.
Excellent command of German (native-level) and English languages.
Complexity and Problem Solving
Works under general direction within the scope of assigned objectives in line with the strategic objectives agreed with International RA Leadership / EU LOC RA and Commercial leadership.
Decides on authority interactions within the framework of Shire EU RA operating model and under general direction of DACH RA Cluster Lead.
Decides on labeling translation quality and on conformity of product information
Accepts or rejects AdProm content and labeling artwork content
Exercises good judgment within generally defined practices and policies in selecting methods and techniques
Informs regulatory authorities on issues/concerns affecting products on the territories, upon consultation with EU RA Strategist
Seeks prior alignment with line management and at European level on questions regarding process definitions / SOPs and regarding submission strategy /dossier scientific content.
Initiate calls / meetings with higher level to communicate / clarify significant questions
Internal and External Contacts
Reports to DACH (Germany-Austria-Switzerland) Regulatory Cluster Lead
Consults internal (EU RA Strategist / GRA teams, local Commercial franchises, R&D, Supply and Quality functions) and external stakeholders (experts, regulatory authorities, trade associations, distributors)
Oversees and instructs third party vendors or contractors who support LOC RA activities
Coordinates with EU RA, QA, International AdProm and Commercial Franchises
Other Job Requirements
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.