Candidate must have extensive experience with vendor management. Also, international agency experience ie: PMDA, EMA, etc. Biotech and Pharmaceutical industry background needed. The candidate will help support the Director but will not have direct reports. They will have to be able to lead meetings, prepare presentations and integrate cross functionally.
The Associate Director International Regulatory Affairs is responsible for developing and
implementing international regulatory strategies to secure and maintain market approval for
marketed and development stage medicines. Leads the international regulatory strategy within
the cross-functional teams. Proactively anticipates and mitigates regulatory risks. Ensures
compliance with international regulatory requirements. Demonstrates an understanding of drug
development and leadership behaviors consistent with level. Develops and implements
acceleration strategies with support from the regional regulatory affairs leads.
• Responsible for developing international regulatory strategies across Horizon’s portfolio
of medicines in conjunction with Global and Regional Regulatory Leads
• Effectively manage multiple projects and responsibilities concurrently
• Ability to thrive in a fast-paced innovative environment while remaining flexible,
proactive, resourceful and efficient are essential.
• Ability to integrate cross-functional issues and balance competing priorities effectively
• Proven ability to communicate clearly and present key information objectively and
collaborate effectively with management.
• Demonstrated ability to clearly and concisely communicate/ prepare presentations for
all levels of management from executive to manager level.
Qualifications and Skills Required
• Bachelor’s degree in life sciences (pharmacy, biology, chemistry, pharmacology) or a
• 8+ years of International Regulatory experience in the Biotech/Pharmaceutical industry
• Experience as a lead regulatory product strategist in two or more major regions such as
EU or Japan.
• Demonstrated experience leading and motivating cross-functional teams
• Outstanding leadership skills including excellent verbal and written communication
skills, an innovative approach to problem-solving, and an integrated view of business
and scientific issues.
• Proficient in Microsoft Office.
• Professional, proactive demeanor.
• Strong interpersonal skills.
• Excellent written and verbal communication skills.
• Transparency: We value collaboration. Trusting teach other and tackling tough
challenges can make a powerful difference.
• Accountability: We do what’s right for our patient communities through quality
decisions and owning our successes and failures.
• Growth: We fiercely innovate and evolve to better ourselves, our communities and our
These three values come to life through our five Leadership Expectations that apply to all
• Enterprise Mindset: Look beyond one’s team, brand or function to see the broader
company and external perspective
• Exhibit Intellectual Curiosity: Seek to understand what you do not know; ask the right
questions of the right people and sources
• Ensure Accountability and Courage: Step up to address difficult issues and hold self and
others accountable to commitments
• Embrace Diverse Perspectives: Welcome others with a respectful attitude; integrate
diverse perspectives into ways of working
• Develop Talent: Provide feedback, coaching and mentorship to help others be more
effective in their role
Remote: Associate Director Regulatory Affairs- International(232466)