Remote: Associate Director Regulatory Affairs- International(232466)

Regulatory Affairs
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Description:

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.

Position Summary

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.

Responsibilities

• 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

related subject.

• 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.

Our Values

• 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

patients.

These three values come to life through our five Leadership Expectations that apply to all

Horizon employees

• 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)

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About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

Start Date
ASAP
Location
Remote, United States

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