Associate Director Regulatory Affairs Biosimilars

Associate Director Regulatory Affairs Biosimilars

• Full-time
• Region: EU+/Canada
• Department: Regulatory

Job Description

About the role

The Biosimilars Regulatory Lead is responsible for directing global regulatory strategies for product maintenance. Responsible for keeping post approval compliance. Responsible for regulatory documents, submissions, and compliance issues. You represent the Company with domestic and international regulatory authorities, contractors, and corporate partners. Provide regulatory guidance and support as needed for various departments and committees.

In this role you will need to handle both operational tasks and leadership responsibilities. You will be actively involved in executional work while also guiding the team's efforts.

Manages direct reports.

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

You will be reporting to the Sr Director

What you'll do

• Responsible for directing & executing global regulatory strategies and operational activities for assigned projects and programs, assessing risk, and developing mitigation plans.
• Directs the work of direct reports in support of regulatory maintenance of assigned programs to meet requirements of Health Authorities and contract partner.
• Provides regulatory guidance to Company personnel on product related regulatory issues with a focus on maintaining compliance.
• Develop and maintain capable and dedicated regulatory staff; guide direct reports in carrying out responsibilities; responsible for coordination/assignment of direct report activities and career development.
• Build and maintain excellent relationships with relevant regulatory authorities, contractors, and corporate partners.
• Assess compliance of documentation/CMC with current Guidelines and Regulations to maintain compliance

Who you are

Ability to work independently with minimal direction and within project teams. You demonstrate good communication skills . Demonstrate organisational skills, including the ability to prioritise workload. Good interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff. Effective cross-cultural awareness and capabilities. Detail oriented with effective written and oral communication skills.

Qualifications

• Bachelor's degree in a scientific or medically related discipline
• Minimum of 8 years in Regulatory Affairs
• Prior experience with Biosimilars preferred
• Previous people management experience is preferred
• You gained relevant experience in interpreting regulations, guidelines, policy statements
• Prior knowledge and understanding of applicable regulations and regulatory pathways
• Experience interfacing with health authorities
• Experience in preparation of regulatory submission documents
• Good verbal and written English skills

Additional Information

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about our DE&I efforts.