Associate Director, Regional Regulatory Lead-US

CSL•Waltham, MA

7d•Hybrid

About The Position

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. Could you be our next Associate Director, Regional Regulatory Lead-US? The job is in our King of Prussia, PA or Waltham MA office. This is a hybrid position and is onsite three days a week. You will report to the Director Global Regulatory Lead. You are a member of the respective GRA GRS Therapeutic Area and contributes to the vision and goals of CSL as: Regulatory leaders who leverage regional regulatory experience / expertise to influence and 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’, effective inputs into risk assessment and decision making. Ensures bi-directional communication with stationed region commercial operations and GRA. Directly 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. May lead 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

Requirements

A bachelor’s degree (four-year university degree) in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science is required.
10+ years’ experience in the biotech or pharmaceutical industry, with at least 5 years of regulatory experience, including 3 years working on developmental products.
Experience in leading teams (preferred 3 years) as a direct or matrix manager, setting direction, holding people accountable and fostering a collaborative, empowered, team environment.
Assess and recommend preferred option for tough decisions.
Candidates have knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in more than one key region (EU, US, Japan)
Experience working in Regulatory Affairs with direct agency interaction responsibility with at least 1 health authority.

Nice To Haves

An advanced degree in a related field (MS, PhD or MD, DVM) or MBA is preferred.

Responsibilities

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.
Actively negotiates on behalf of CSL with health authority to achieve desired
Regional expert regarding health authority requirements, regulatory filing pathway / categories, processes and ways of working and thus, can provide sound 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, leads regional regulatory activities as assigned, inclusive of potential to lead 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 leads 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.