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 proactive 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 and proven skill at developing and implementing 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:
Bachelor’s degree in Pharmacy, Biology, Chemistry or other related life science
Minimum 7 years of experience in the biotech/pharmaceutical industry (or equivalent)
Minimum 5 years of experience in regulatory (or equivalent)
Minimum 3 years of experience in leading and managing matrix teams (or equivalent)
Preferred:
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
