Shire Nordic-Baltic Regulatory Affairs Cluster Lead in Stockholm, Sweden
The successful candidate will have overall responsibility for the management and strategic direction of the RA function in the Nordic-Baltic cluster, including Sweden, Denmark, Norway, Finland, Iceland, Estonia, Latvia and Lithuania
• Ensure compliance of marketing authorisation dossiers with local regulatory requirements
• Accountable for adherence of the RA function to the Corporate Quality System
• Foster and maintain relationship and communication with competent regulatory health authorities in the Cluster
• Assume RA responsibilities for new products and lifecycle management in support of EU RA Strategists, GRA and local operating companies (LOC)
• Act as RA Representative in NORBALT Leadership Team and R&D Council
Provide leadership to a team of several RA professionals located within LOC offices in the cluster
Support Country RA team design and resourcing to meet local regulatory requirements
Ensure staff hiring, training and development
Accountable for goal setting, performance monitoring, workload distribution and team governance
Ensure alignment of RA Team focus with global R&D and regional franchise strategies
Develop and manage the budget
Drive continuous improvement and simplification of processes in close collaboration EU RA leadership and local partners
Creates an open collaborative environment within LOC stakeholders and Global functions
COUNTRY RA PRODUCT RESPONSIBILITIES
Assign product responsibilities in the team; may assume personally part of product portfolio activities, and ensure oversight
Ensure handling of marketing authorization submissions and variations in close collaboration with EU RA Strategy team according to Shire EU RA operating model and local regulations
Ensure final product labeling in compliance with CCDS
Ensure regulatory review and approval of promotional materials
Ensure appropriate RA support for local product launches and early access programs
Ensure appropriate contract and oversight is in place with any external partners who support Regulatory Affairs activities for the cluster
Represent the NORBALT region at European and International RA level and support the EU regional alignment on LOC RA working practices
Support the European RA leadership on ad hoc issues or lead European alignment on topic areas assigned by Head RA EU LOC.
Act as RA representative in the NORBALT Leadership Team and R&D Council to ensure “One R&D voice” is delivered in the cluster
May be asked to oversee certain clinical trial authorization submissions to local competent authorities
NATIONAL REGULATORY AUTHORITY INTERACTIONS
Be the primary contact for regulatory health authorities (HA) in national (phase of) procedures and post-approval, including HA liaison regarding field corrective actions / direct healthcare professional communications, risk minimisation measures or supply constraints.
Support EU regional RA strategists in their regulatory authority communication related to European submissions and management of scientific advice meetings
REGULATORY INTELLIGENCE & RA INSPECTION-READINESS
Proactively follow the evolution of local regulatory landscape, monitor applicable local regulations and ensure clear communication of country regulatory requirements to cluster functions and global RA
Ensure permanent inspection-readiness of RA function in accordance with local regulations and internal standards and policies
Ensure timely local implementation and tracking of safety labeling changes
Ensure 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
Implement Global/Regional Shire SOPs into local RA practice; where necessary, create local SOP addenda
Support as applicable the planning, execution and follow-up of internal audits and HA inspections in conjunction with Quality functions
Education and Experience Requirements
• Master Degree in Pharmacy or Life Sciences (Ph.D. or Pharm.D preferred).
• Minimum 15 years in pharmaceutical environment including significant regulatory affairs responsibilities in a multinational company or health authority
• Proven experience and relationship with Regulatory Authorities in the cluster.
• Several years experience in people management
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
• Demonstrated ability to motivate, mentor, and develop a diverse team
• Proven interpersonal, communication, analytical, and organizational skills
• Ability to challenge self and others to overcome barriers and deliver high quality solutions
• Able to deal with complex and sensitive issues
• Able to drive alignment between functional and commercial objectives
• Strong judgment and decision-making skills with the ability to recommend appropriate risk-taking and understanding how decisions fit into the broader context of corporate strategies.
• Effectively embraces change and is able to flourish in a global structure, aligning people and processes to deliver excellence.
• Ability to effectively manage multiple competing tasks and work in a fast paced environment;
• Consistently exhibits Shire’s Leadership Behaviors and integrates Shire's Code of Ethics into all aspects of business activity.
• Excellent command of English and a Nordic language (native speaker preferred), competency in further languages of the cluster is a plus
Complexity and Problem Solving
Describe the decisions made by the incumbents on a regular basis. Include decisions within the
Incumbent’s authority to make as well as those decisions that must be referred to a higher level.
• Works autonomously in line with the strategic objectives agreed with International RA Leadership / EU LOC RA and Commercial leadership.
• Decides independently on workload assignment, resolution of local regulatory issues and staff training within the framework of Shire EU RA operating model.
• Accepts or rejects AdProm content and labeling artwork content
• Takes lead on assessing complex challenges linked to commercial initiatives and makes considered and strategic recommendations within the range of experience.
• Informs regulatory authorities on issues/concerns affecting products on the territories, upon consultation with EU RA Strategist
• Seeks prior alignment 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
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.
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.