Manager, Regional Regulatory Lead - LCM

CSL Plasma•Waltham, PA

1d•Hybrid

About The Position

Regulatory leaders who leverage regional regulatory experience to actively contribute to an innovative, scientifically sound, global, integrated regulatory vision/strategies for assigned product/s with a patient-centric focus, leveraging regional commercial insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes. Effectively partner with assigned product/s Global Regulatory Affairs Strategy Team (GRAST) GRL plus other regional, labeling and CMC GRAST members to ensure ‘One GRA Voice’, appropriate inputs into risk assessment and decision making. Ensures bi-directional communication with stationed region commercial operations and GRA. With support, engaging with health authority (HA) in stationed country (FDA or EMA), maintaining productive relationship with HA contacts and driving positive regulatory outcomes with respective HA for assigned product/s in conjunction with GRL. Contributes to product health authority interaction with support GRL or Regulatory TA Head. Partner with GRAST members to achieve regulatory deliverables (including leading assigned tasks) while fostering individual accountability, ‘team spirit’, actively contribute and executing on decisions expeditiously resulting in positive regulatory outcomes. This is a hybrid position based in King of Prussia, PA or Waltham, MA with a minimum of 3 days onsite in the designated work location weekly. Relocation and mobility assistance are not provided.

Requirements

Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, Clinical Medicine, or related life science field.
Minimum of 5+ years of regulatory/submission experience in the biotech or pharmaceutical industry
3+ years of experience working on developmental products
Knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in one or more key regions (EU, US, Japan)
Experience working in Regulatory Affairs with agency interaction responsibility with at least one health authority is preferred.
Relevant experience working in a complex and matrix environment.
Demonstrated ability to think strategically, assesses prudent risks and develop bold, agile, innovative approaches to complex challenges
Proven effective verbal and written communication skills and ability to successfully work across all levels of the organization
Foster productive, working relationships within CSL (e.g., R&D and Commercial).

Nice To Haves

Advanced degree in a related field (MS, PhD, or MD, DVM) or MBA is preferred
Ideal candidates will have clinical or device foundation

Responsibilities

With support, accountable for assigned product relationship with a health authority (FDA or EMA), ensuring alignment with product GRL and as needed, support from Head, Regulatory TA if escalation is required.
May negotiate on behalf of CSL with health authority to achieve desired regulatory outcome.
Developing regional knowledge regarding health authority requirements, regulatory filing pathway/categories, processes, and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders (e.g., GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new, and marketed products.
Under the product GRL, supports regional regulatory activities as assigned, inclusive of potential to contribute to core document preparation (e.g., core briefing book, pediatric plans, etc.), product filing preparation activities (investigational, new, and marketed) and health authority engagements.
Responsible for Module 1 documentation required for submission and supports response to health authority comments activities with guidance from GRL.
Actively contribute to the GRAST activities, strategy development, document reviews and competitive regulatory intelligence.
Ensures on-time execution of regulatory activities at the regional level, achieving positive regulatory outcomes.
Partners with GRL to develop internal communications and distributes GRAS communications to regional commercial stakeholders.
Actively connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC.
Proactively fosters and promotes effective relationships across Global Regulatory Strategy.
Updates and maintains applicable regulatory systems (e.g., Veeva) to ensure tracking and compliance deliverables.
Applies the CSL Leadership Capabilities – Build Bridges, Think Beyond, Unleash Outcomes, Ignite Agility, Inspire the Future and Cultivate Talent – to oneself.