Who we are

How you’ll spend your day

As the Associate Director, Regulatory Affairs you will be responsible for acting as and supporting the Global Regulatory Lead (GRL) in strategic vision and innovative scientific and regulatory leadership in defining the global regulatory strategy for biosimilar (BioS) projects. You will be accountable to lead and/or support the Global Regulatory Affairs (GRA) Team for assigned projects to ensure alignment of the regional, clinical and Chemistry Manufacturing and Controls (CMC) regulatory strategies with the overall global strategy. In addition you will have responsibility for ensuring and assisting other GRLs in ensuring collaboration with key internal stakeholders of the Core Project Team (CPT), Clinical Development Team (CDT), and CMC Team to ensure successful planning and execution of the global regulatory strategy for assigned projects.

Other duties:

• Spearhead the delivery of successful investigational and regulatory license applications and product life cycle management submissions with the Global Regulatory Affairs Team from initial filing through post-approval management
• Provide pro-active support the regional strategic leads on the establishment and maintenance of high quality working relationships with the FDA, EMA, PMDA and other global regulatory agencies as appropriate for assigned products
• Drive regulatory strategic decision making necessary to ensure planning and execution of successful global regulatory strategies, submissions and approvals for assigned biosimilar project(s)
• Interface with project teams and regulatory agencies, demonstrating a proven ability to develop and implement successful global regulatory strategies
• Effectively manage a team/direct reports to ensure successful planning and execution of the global regulatory strategy for assigned projects

Your experience and qualifications

Required Qualifications:

• Bachelor’s degree in Pharmacy, Biology, Chemistry, or other related life science
• Minimum 7 years of experience in the biotech/pharmaceutical industry
• Minimum 5 years of experience in regulatory
• Minimum 3 years of experience in leading and managing matrix teams

Preferred Qualifications:

• Advanced degree (MS/PhD in pharmacy, biology, chemistry, pharmacology or related life science, MBA, or MD)
• Minimum 10 years of experience in the biotech/pharmaceutical industry
• Minimum 7 years of experience in regulatory and minimum 3 years in commercial organization
• Minimum 5 years of experience in leading and managing matrix teams
• Minimum 3 years of experience working with biologics/biosimilars
• Minimum 3 years of experience working with sterile products/manufacturing within biotech/pharmaceutical industry
• Knowledge and understanding of pharmaceutical/biological/biosimilar product development and regulatory requirements for product development and approval in more than one key region (EU, US, Canada, Japan) as well as life cycle management of products
• Experience working in Regulatory Affairs in a global environment across two or more geographic areas (preferentially US and EU)
• Experience in evaluating Change Requests/Change Controls for regulatory documents and providing accurate regulatory assessments

Enjoy a more rewarding choice

We offer a competitive benefits package, including Medical, Dental, Vision, and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 13 paid Holidays, 6% match on the 401(k), Employee Stock Purchase Plan, and Tuition Assistance.

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