Teva Manager Regulatory Affairs - Biosimilars 

United States, Pennsylvania, East Bradford Township 

635299232

• The Manager is responsible for supporting the Regulatory Affairs strategic vision and regulatory leadership in defining the global regulatory strategy for biosimilar projects.
• The Manager is accountable to support the Global Regulatory Affairs Strategy Team (GRAST) for assigned projects to ensure alignment of the regional and Chemistry, Manufacturing and Controls (CMC) regulatory strategies with the global regulatory strategy.
• The Manager will assist the Global Regulatory Lead and other RA Team members in ensuring successful planning and execution of the global regulatory strategy for assigned projects.
• The Manager will contribute to the delivery of successful regulatory license applications and product life cycle management submissions in close cooperation with the GRAST members (Regional Strategic Leads, Global Regulatory CMC lead, Global Strategic Labeling/ Ad Promo Lead, Global Regulatory Operations Lead).
• The Manager will 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 therapeutic areas and products.
• Responsible to assist RA Team members in planning and execution of successful global regulatory strategies, submissions and achieving approvals for assigned biosimilar project(s).
• Responsible to assist RA Team members in preparing meeting packages for the Health Authorities (HAs) in the EU, US and additional HAs as required. This includes Scientific Advice (SA) in the EU and Biosimilar Biological Product Development (BPD) meetings in the US.

• Bachelor's degree in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science is preferred.
• Minimum 6 years of experience in the biotech or pharmaceutical industry, with at least 5 years in Regulatory Affairs.
• Ideal candidates will have a strong clinical, CMC and biosimilar foundation.
• Must have knowledge and understanding of pharmaceutical/biological/biosimilar product development, regulatory requirements for product development and approval in more than one key region (e.g., EU, US, Japan), and life cycle management of products.
• Experience working in Regulatory Affairs in a global environment.
• Ability to assess technical quality of documents and to provide regulatory feedback to colleagues.
• Experience populating and maintaining databases (e.g., Veeva) and trackers in real time (e.g., workload trackers).
• Experience utilizing electronic Common Technical Document format to compile Health Authority submissions.
• Experience working in matrix teams with multiple stakeholders.
• Experience with Health Authority interactions preferred, e.g., FDA BPD and EMA SA.
• Ability to lead internal cross-functional team meetings.
• Escalates project issues and risks to management appropriately.
• Prepare and review regulatory submissions (i.e., BLAs, amendments, supplements, etc.) to ensure compliance with applicable regulations and guidance's.
• Assist in the preparation of Health Authority meeting minutes.
• Performs role in accordance with the organization’s policies, procedures, and state, federal and local laws.

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