CSL's R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a focus on collaboration, we’re building a future-ready team that thrives in dynamic biotech ecosystems. Joining CSL now means being part of an agile team committed to developing therapies that make a meaningful difference worldwide.

Position Overview: 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 Waltham, MA or King of Prussia, PA with a minimum of 3 days onsite in the designated work location weekly. Relocation and mobility assistance are not provided.

Key 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.

Minimum Qualifications: Bachelor’s degree in Pharmacy, Biology, Chemistry, Pharmacology, Clinical Medicine, or related life science field. Advanced degree in a related field (MS, PhD, or MD, DVM) or MBA is preferred 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. Ideal candidates will have clinical or device foundation 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).

The expected base salary range for this position at hiring is $129,000 - $153,000/yr. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the Waltham, MA USA work location at the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors.

In addition to base salary, total compensation for this role may also include incentive compensation and equity. LI-HYBRID

The Role: Acts as Case Management subject matter expert in cross-functional teams for assigned clinical trials. Manages case management activities for assigned clinical studies to ensure compliance with national and international regulations, such as GxP guidelines and/or other relevant international and national legislation, regulations, guidance, and company policies and procedures within the area of responsibility. Manages the delivery of the Safety Reporting Plans, ; identifies, implements, and monitors KPIs/KQIs across clinical case management activities; Supports the preparation and conduct of PV and other GxP inspections and audits, as required, . Establishes, maintains, and/or ensures maintenance of clinical trial case management required documents, such as safety reporting plans and reporting responsibilities , in line with international and national regulations, guidelines, and internal standards. Oversee the Vendors to ensure GSPV standards are maintained with respect to processing of SAE, AESI and pregnancy clinical trial cases and compliance with respect to expedited reporting in clinical trials. Act as primary contact for external vendors for all GSPV PV Operations clinical trial queries pertaining to their assigned Clinical trials. Prepare & Provide Study specific training to external vendors and GSPV team members involved in the given clinical trial. Participate in any drug safety database enhancements and upgrades by providing input from a clinical trial perspective. Develops, implements, and oversees pharmacovigilance procedures and processes and ensures the uniform and timely processing and analysis of safety data to comply with regulatory requirements. Ensures correct coding of all event and drug terms. Ensures inter- and intra-consistency for case evaluations. Leads or oversees ICSR reporting compliance analyses provided by vendors and associated CAPAs from clinical trial case management. Acts as a liaison internally and with external collaborators to develop processes that meet regulatory reporting requirements. Oversees preparation of Suspected Unexpected Serious Adverse Reactions for submission to external regulatory agencies. May lead or contribute to cross-functional projects to fulfill GxP requirements and improve inspection readiness.

Skills and Experience: Bachelor's degree or equivalent in a life science discipline (e.g., nursing, biological sciences, pharmaceutical sciences, or Medical Documentation). Master's or PhD in Life Sciences preferred. 7 years of Pharmacovigilance experience in a multinational pharmaceutical industry environment. Expert knowledge of local and international regulations and PV processes. Knowledge of local and international GxP regulations, IT standards, and other relevant legislation, including privacy protection requirements.

Experience with regulatory inspections.

Experience administering complex data sets.

Experience managing CAPA and SOP development projects.

Experience with relevant software applications.

Experience working within a GxP-regulated environment.