Associate Director Regulatory Affairs Biosimilars

Biogen; Baar; Hybrid; EUR 70.000 - 110.000; Vollzeit

Zusammenfassung

An established industry player is seeking a Biosimilars Regulatory Lead to drive global regulatory strategies and ensure compliance. This pivotal role combines operational tasks with leadership, guiding a capable regulatory team while fostering relationships with regulatory authorities and partners. The ideal candidate will have extensive experience in Regulatory Affairs, particularly in Biosimilars, and possess strong communication and organizational skills. Join a dynamic team committed to delivering life-changing medicines and making a significant impact in the biotech field.

Qualifikationen

• 8+ years in Regulatory Affairs with a focus on Biosimilars preferred.
• Proven ability to interpret regulations and prepare submission documents.

Aufgaben

• Direct global regulatory strategies and manage compliance for projects.
• Lead a team in regulatory maintenance and build relationships with authorities.

Kenntnisse

Regulatory Affairs

Communication Skills

Organizational Skills

Interpersonal Skills

Cross-Cultural Awareness

Ausbildung

Bachelor's degree in a scientific or medical discipline

Jobbeschreibung

Job Description

About the role

The Biosimilars Regulatory Lead is responsible for directing global regulatory strategies for product maintenance, ensuring post-approval compliance, managing regulatory documents, submissions, and compliance issues. You will represent the company with domestic and international regulatory authorities, contractors, and corporate partners, providing regulatory guidance and support across departments and committees.

This role involves both operational tasks and leadership responsibilities, requiring active involvement in execution while guiding the team.

You will manage direct reports.

Location: Baar, Switzerland (our local hybrid policy requires 50% office presence)

Reporting to the Sr Director.

What you'll do

• Direct and execute global regulatory strategies and operational activities for assigned projects, assessing risks and developing mitigation plans.
• Lead the work of direct reports to support regulatory maintenance, ensuring compliance with health authorities and contract partners.
• Provide regulatory guidance to company personnel on product-related issues to maintain compliance.
• Develop and maintain a capable regulatory team, guiding responsibilities and supporting career development.
• Build and sustain relationships with regulatory authorities, contractors, and partners.
• Assess documentation and CMC compliance with current guidelines and regulations.

Who you are

You are able to work independently with minimal guidance and collaborate effectively within project teams. You possess strong communication, organizational, and interpersonal skills, capable of prioritizing workload and engaging with diverse personnel including medical, scientific, and manufacturing staff. You demonstrate cross-cultural awareness, attention to detail, and excellent written and oral communication skills.

Qualifications

• Bachelor's degree in a scientific or medical discipline
• Minimum of 8 years in Regulatory Affairs
• Experience with Biosimilars preferred
• People management experience is a plus
• Proven ability to interpret regulations, guidelines, and policies
• Knowledge of regulatory pathways and experience interfacing with health authorities
• Experience preparing regulatory submission documents
• Fluent in English, both verbal and written

Additional Information

Why Biogen?

We are a global team committed to excellence and innovation. As a mid-sized biotech company, we offer stability and resources while fostering an environment for growth and impact. Our talented team works together to deliver life-changing medicines, with every role contributing to our mission of caring deeply, achieving excellence, and changing lives.

We value diversity and inclusion, reflecting the communities we serve and the patients we help. Our culture promotes empowerment and inspiration for all employees. Learn more about our DE&I efforts.