Senior Director, Regulatory Affairs Eu

hace 7 días

Barcelona, Barcelona, España AstraZeneca A tiempo completo

This role is the key account manager for the regulatory EU Marketing Company (EUMC) thereby managing and coordinating all EU regulatory affairs CP-related matters in close collaboration with local EU Marketing Company Regulatory Affairs (MCRA) Heads, EU marketing company presidents and all relevant Global Functions.


Internal Focus:

  • Responsible for EUMC legal accountabilities are met.
  • Leads the EU Regulatory Coordination Team (EU RCoT)
  • Works with local EU MCRA Heads and Global Functions to define, support and deliver the overall EU regulatory strategy and workplan with appropriate resourcing at local level.
  • Ensures EU specific regulatory legislation are fully embedded in the overall AZ organization.
  • Is the main link into the global regulatory Therapeutic Area (TA) organizations ensuring aligned ways of working and consistent and timely communication from and towards EU MCRA is delivered for centralized registered products.
  • Ensures that the regulatory operating model and toolkits address EU MCRA needs.
  • Is member of the TA Executive Directors Network.
  • Provides the MC regulatory input into EU issue management resolution.
  • Promote, contributes, facilitates, and occasionally leads innovative strategies to partner with the relevant EU regulatory authorities to optimize the predictability of the regulatory outcome and to provide the regulatory platform for optimizing and maintaining market access in the allocated Markets driving launch excellence.
  • Partners and collaborates effectively with key internal stakeholders outside regulatory such as EU and TA Commercial, EU Marketing Companies, EU Medical and Market Access to ensure launch excellence.
  • Ensures the global regulatory organization provides an excellent service to customers in EU Marketing Companies by enabling rapid and effective submissions and approvals; and seeking to enhance relationships and profile with local Regulatory Authorities.
  • Ensures appropriate communication and sharing of relevant EU competitive intelligence information in close collaboration with the RA TA Intelligence functions.
  • Ensures best practices are shared within global regulatory.
  • Coaches and mentors EU MCRA staff where needed.

External environment:

  • Together with the EU Policy Directors monitors changes in the regulatory environment to support and advise the EU MCRA, EU businesses, global teams, functions and global regulatory with respect to AZ strategic positions.
  • Creates, develops, and optimizes relationships with regulatory agencies, trade associations, and internal groups together with EU MCRA Heads
  • Ensures self or others actively represent AZ outside the company (for example trade association meetings) to engage and shape policy on key TA issues to facilitate efficient and effective drug development in the EU.
  • Coaches and leads definition of innovative strategies to partner with the relevant regulatory authorities to optimize the predictability of the regulatory outcome and to provide the regulatory platform for optimizing and maintaining market access in the allocated Markets.
  • Partners and collaborates effectively with key external stakeholders such EU regulators, Health Authorities, Trade Associations etc.

Education, Qualifications, Skills and Experience

Essential

  • Bachelor's degree in life sciences and/or science related field and/or other appropriate knowledge/experience.
  • More than 10 years of regulatory affairs experience
  • Experience in global regulatory strategy and submissions that have progressed through to registration
  • Must have significant experience in leading major health Authority interactions
  • Ability to work closely with Country Commercial Organization and interact with Regional Leadership and Country Leadership
  • Broad background of experience working in pharmaceutical/medical industry and prior experience in several areas within regulatory affairs, e.g. Global, European, International, Marketing Company or experience at a health authority, as well as experience to interact with Region's Officials (e.g., European Commission, European Parliament)
  • Experience in managing people in a matrixed organizational structure.
  • Ability to think strategically and critically to evaluate risks to regulatory product development and approval, market entry and license maintenance activities for the Region with effective judgement and decisionmaking in complex business critical situations.
  • Strategic influencer of key stakeholders/leaders, innovative, taking initiative, and strong leadership.
  • Excellent collaboration, team working, oral and written communication skills.
  • Willingness to undertake domestic/international travel.

Desirable

  • Advanced degree in a scientific discipline (e.g. MSc, PhD, PharmD, MD)

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