European Regulatory and R&D Policy Senior Manager

  • Amgen
  • Uxbridge, GB
  • Private Sector
  • 3 weeks remaining

Amgen is one of the world’s largest independent biotechnology companies, with global revenue of $23 billion and nearly 20,000 employees globally. For more than 35 years, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world.

The Team

This role reports to the Head of European Regulatory and R&D Policy and may include significant domestic and international travel to support policy activities. The successful candidate is a solutions-orientated self-starter that has demonstrable experience in managing a European regulatory and legislative policy agenda to create an optimal regulatory environment rewarding of innovation in biologic therapies.

Responsibilities Include

  • Participating in the development and articulation of Amgen’s positions on regulatory and R&D policies that impact Amgen’s business.
  • Master a range of bio-pharmaceutical R&D topics, ranging from digital health and precision medicines, through to patient centricity and geo-political uncertainty.
  • Provide coverage of European regulatory issues pertaining to the Biosimilars market with regularly refreshed impact assessments.
  • Support the development of advocacy strategies, manage and execute fully resourced advocacy work plans in concert with Policy Directors and other internal stakeholders.
  • Deliver coherent and sophisticated environmental analysis and policy insights to group, including identification of changes needed to European health systems.
  • Leading and/or engaging on cross-functional teams to establish priorities and execute strategic and long-term advocacy plans for the advancement of Amgen’s policy goals
  • Providing internal stakeholders with a strategic regulatory and R&D policy perspective
  • Representing Amgen in interactions with external regulatory, political, policy NGO and professional organisations in a manner that aligns with the ‘one-Amgen’ approach
  • Implement strategies/processes to support European Affiliates and priority markets. Collaborate with Policy Directors and sub-regional leads to contribute to local Government Affairs & Policy plans. Identify opportunities for engagement with EU Institutions to support Affiliates’ plans.
  • Develop and maintain metrics dashboard to ensure progress against policy objectives and advocacy work plans. Ensure progress is maintained with regular project management review meetings with Policy Directors.
  • Engage in continuous analysis and improvement of processes, systems and tools employed within the function, and ongoing creative initiatives

Minimum Requirements/Qualifications

Master’s degree in public health, life sciences, public policy, business administration and/or a law degree.

Preferred Requirements/Qualifications

 

  • Demonstrable experience in policy development, analysis and influencing
  • Excellent written and oral communication skills, highly analytical and capable of communicating complex information clearly across various levels both inside and outside of our organisation.
  • Experience building and leveraging relationships within Brussels-based industry associations preferred (e.g., EFPIA)
  • Experience in designing and managing creative advocacy campaigns to advance policy positions to key decision-makers.
  • Be an adept project manager, able to coordinate the delivery of creative multi-channel communication programmes across different, yet interconnected policy topics.
  • Must demonstrate strong communication, collaboration, and interpersonal skills; the ability to build and maintain trusting relationships
  • Related experience of working within bio-pharmaceutical, clinical diagnostics, life science sector is an advantage. Alternatively, experience of working within a compliance-led highly-regulated sector will be considered.
  • Understand impact of regulatory and R&D environment on all areas of the bio-pharmaceutical business, and actively seek synergies.
  • Experience in government or a regulatory authority would be welcomed.

 

Location:

Uxbridge, UK. Successful candidate can be also located in Breda, Brussels, Milan, Paris, Moscow or Vienna.

Remuneration

Competitive salary & comprehensive benefits package including bonus schemeAmgen is an equal opportunities employer


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