Senior Manager, Regulatory Affairs

CSL; United States; Hybrid; USD 120,000 - 160,000; Full time

Job summary

A leading biotechnology firm seeks a Senior Manager Regional Regulatory Lead to develop and implement global regulatory strategies for innovative therapies. Located in King of Prussia, PA, this hybrid role requires a minimum of 7 years in the biotech or pharmaceutical industry and proven regulatory experience, especially with health authorities like the FDA and EMA. Join a dynamic team dedicated to impacting patients' lives positively.

Qualifications

• Minimum of 7 years’ experience in the biotech or pharmaceutical industry.
• Experience with at least one health authority agency interaction.
• Developing knowledge of product development and regulatory requirements.

Responsibilities

• Develop global regulatory strategy for assigned products.
• Lead interactions with health authorities like FDA and EMA.
• Mentor team members and drive regulatory deliverables.

Skills

Regulatory Affairs experience

Team leadership

Agency interaction

Pharmaceutical/biological knowledge

Education

Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science

Job description

Overview

Talent Acquisition Partner at CSL Behring

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

The position is Senior Manager Regional Regulatory Lead, located in King of Prussia, PA. This is a hybrid role in which you are onsite three days a week. You will report to the Executive Director Head Regulatory.

Responsibilities

• Regulatory leaders who support development of a global, integrated regulatory strategy ensuring innovative, scientifically sound regulatory vision and strategies for assigned product/s with a patient-centric focus.
• Leads as a key member, partner and single GRA representative for the respective Product Strategy Teams (PST) and/or related global R&D/commercial teams, and leads the Global Regulatory Affairs Strategy Team (GRAST) to ensure connectivity and engagement with internal GRAS partners.
• Support or lead health authority interactions in the stationed country (FDA or EMA) and maintain productive relationships to drive favorable regulatory outcomes with FDA, EMA and global health authorities.
• Engage GRAST members to achieve regulatory deliverables, assign tasks, foster accountability and act as regulatory decision maker/approver for GRAST/GRA project deliverables as needed, promoting effective two-way communication between GRAST and R&D teams.
• As GRA representative, build relationships with Product Strategy Team (PST), Clinical Development Team (CDT), Safety Management Team (SMT) and/or Device/EHT related development teams to ensure bi-directional dialogue across research, development and commercial functions.
• Support assigned product relationships with key health authorities (FDA & EMA), including CSL contact for home country and content/approach in all global health authorities; escalate topics with the Regulatory Affairs Head as needed.
• Serve as the single GRA reviewer and, as necessary, approver of deliverables (e.g., protocol, Target Product Profile) generated from PST, CDT, SMT and related teams; may lead discussions at Global Regulatory Forum (GRF) or with senior management.
• Lead GRA project deliverables (e.g., Core Briefing Books, Orphan Drug Designation, Pediatric Study Plans) and mentor GRAST members as appropriate.
• Leverage GRAST, competitive regulatory intelligence/AI, business insights/analytics and other regulatory functions (e.g., device/combination products) to deliver Global Regulatory Strategy Outlines for portfolio.

Qualifications & Experience

• Bachelor’s degree (four-year university degree) in pharmacy, biology, chemistry, pharmacology, clinical medicine or related life science.
• Minimum of 7 years’ experience in the biotech or pharmaceutical industry, with at least 5 years of regulatory experience.
• Experience working in teams with either direct or matrix management; ability to assess options for tough decisions.
• Developing knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in one key region (EU, US, Japan).
• Experience with agency interaction responsibilities with at least one health authority.
• Regulatory Affairs experience with agency interactions required.
• #LI-HYBRID

Employment type

• Full-time

Job function

• Research

Note: This description focuses on the Senior Manager Regional Regulatory Lead role and its requirements. Related job postings listed elsewhere are not part of the role description.