This position serves as the Regulatory Regional Manager, Regulatory Affairs North America representative on project teams for assigned development products.
Responsible for ensuring the regional regulatory strategy is aligned with the global regulatory strategy for assigned projects.
Supports the Therapeutic Area Leads 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 Health Authority approval in the fastest and most efficient way while ensuring quality documentation and compliance with the regional regulatory requirements.
Leads FDA meetings for assigned projects. 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.
Main Responsibilities and Accountabilities:
- Serve as Regulatory Regional Manager, Regulatory Affairs North America for allocated product portfolio: Develop regional regulatory strategies considering regional requirements, scheduling and priority setting .
- Ensure all regulatory activities are in alignment with the strategic direction of the Global Regulatory Affairs Strategy Team (GRAST)
- 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 health authority (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.
- Lead contact with HA for all assigned projects. Lead HA meetings from a regulatory perspective for all 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.
A degree in a scientific background, preferably with a post-graduate qualification. Certification/Degree in Drug Regulatory Affairs advantageous.
• At least 5 years of regulatory experience in a regulatory authority facing role, supported by additional pharmaceutical /industry experience.
• Experience with drug development and CBER requirements.
• Demonstrated working knowledge of regulatory guidelines and legislative requirements for 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.
• Ability to successfully identify the needs of internal and external customers and deliver on those needs while meeting business objectives.
Share:State/ProvincePennsylvaniaCityKing of PrussiaStreet Address1020 First AvenuePrimary LocationCSL Behring King of Prussia