Regulatory Regional Manager/Senior Manager
Plans and manages regulatory activities on both new and in-line products in accordance with health authorities. Defines or ensures registration strategy and planning. Organizes the preparation, submission and follow-up of medical affairs and authorities. Organizes and archives registration files. Ensures that all the aspects of the product safety are closely monitored and fulfill the regulatory requirements.
This position serves as the regional Regulatory Affairs North America Development Products (RA NA DP) Senior Manager (RA) representative on project teams for assigned development products
The RA NA DP Senior Manager is responsible for ensuring the regional regulatory strategy is aligned with the global regulatory strategy for assigned development projects.
Supports the Global Regulatory Leads (GRLs) and other Global Regulatory Affairs (GRA) vision of excellence regarding license applications for assigned projects through strategy, good scientific practice, integrity and consistent compliance with local regulatory standards. Works closely and in cooperation with regional and local regulatory offices for submission and approval of BLAs, sBLAs, with a view to obtain HA approval in the fastest and most efficient way while ensuring quality documentation and compliance with the regional regulatory requirements.
Interacts with Global Regulatory Leads (GRLs) to manage and resolve cross-functional issues.
Actively supports regional efforts to establish and maintain effective working relationships with respective regional regulatory agencies and other key external stakeholders
• Develop regional regulatory strategies considering regional requirements, scheduling and priority setting
• Ensure all regulatory activities are in alignment with the strategic direction of the GRAST-DP
• Contribute to a GRA Strategy Document for complex projects and provide review of regional regulatory strategies
• Participate in GRASTs, and as applicable provide regulatory guidance on regional, regulatory procedures and HA requirements
• Contributes to the compilation of high quality documentation for submissions in the region ensuring content and format requirements are met
• Lead the preparation and contribution of briefing packages for assigned projects
• Communicate submission dates and approval dates to stakeholders, as applicable
• Ensures timing of submissions are met with agreed upon timelines
• Serve as Health Authority contact for all assigned projects
• Lead HA authority meetings from a regulatory perspective for assigned projects
• Develop and maintain effective working relationships with regional regulatory agencies demonstrated by high quality communication and effective use of negotiation skills to achieve positive outcomes for CSL Behring
• Support the GRL/product specialist for the strategy, planning and preparation of response for complex scientific questions requiring product expertise and contacting internal stakeholders
• Independently provide responses to simple, routine requests not requiring product expertise or input from other internal stakeholders
• Monitor current and proposed regulatory requirements to provide applicable regulatory advice to project teams to ensure HA compliance while meeting business objectives
• Mentor Regional Managers and /or Regulatory Specialists
Requirements:
Education
A degree in a scientific background, preferably with a post graduate qualification.
Certification/Degree in Drug Regulatory Affairs advantageous.
Experience
• Seven to 10 years of regulatory experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience.
• Extensive experience with drug development and strong working experience with CBER requirements
• Demonstrated working knowledge of regulatory guidelines and legislative requirements of both international and (relevant) regional Regulatory Authorities.
• Understanding of the principles of GMP, GCP and GLP.
• Strategic and tactical thinking ability, complemented by a hands on operational approach and business planning orientation.
• Ability to identify the ?big picture and opportunities/major issues and link day to day tasks with long term goals.
• Demonstrated ability to deal with rapid change.
• Demonstrated sound judgment and flexible approach to managing situations.
Worker Type:
Employee
Worker Sub Type:
Regular
