Associate Director, Regional Regulatory Lead-US
BioSpace, King Of Prussia, PA, United States
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 contribute to the vision and goals of CSL. You will serve as a regulatory leader who leverages regional regulatory experience and expertise to influence and actively contribute to an innovative, scientifically sound, global integrated regulatory vision and strategy for assigned products with a patient‑centric focus. You will apply regional commercial insights and prudent risk‑taking to ensure timely delivery of successful regulatory outcomes.
Effectively partner with the assigned product’s Global Regulatory Affairs Strategy Team (GRAST), GRA, and other regional, labeling and CMC GRAST members to ensure a unified GRA voice, effective inputs into risk assessment and decision‑making, and bi‑directional communication with stationed region commercial operations and GRA.
Directly engage with health authorities (FDA or EMA) in the stationed country, maintaining productive relationships with HA contacts and driving positive regulatory outcomes for assigned products in conjunction with the Global Regulatory Lead. You may also lead product health‑authority interactions with support from the GRL or Regulatory TA Head.
Partner with GRAST members to achieve regulatory deliverables, including leading assigned tasks while fostering accountability, team spirit, and expeditious decision execution that results in positive regulatory outcomes.
Responsibilities
Accountable for the assigned product relationship with a health authority (FDA or EMA), ensuring alignment with the product GRA Lead and, as needed, support from the Head, Regulatory TA in case of escalation. Actively negotiate on behalf of CSL with the health authority to achieve desired outcomes.
Serve as the regional expert on health‑authority requirements, regulatory filing pathways/categories, processes, and ways of working. Provide sound guidance and assessment to internal stakeholders (e.g., GRAST, GRA Lead & Commercial) on how to address project challenges, leverage regulatory opportunities, and advise on risk for developmental, new, and marketed products.
Under the product GRA Lead, lead regional regulatory activities as assigned, including the preparation of core documents (e.g., core briefing book, pediatric plans), product filing preparation activities (investigational, new and marketed), and health‑authority engagements. Responsible for Module 1 documentation required for submission and for leading responses to health‑authority comments with guidance from the GRA Lead.
Actively contribute to GRAST activities, strategy development, document reviews, and competitive regulatory intelligence. Ensure on‑time execution of regulatory activities at the regional level, achieving positive outcomes. Partner with the GRA Lead to develop internal communications and distribute GRA communications to regional commercial stakeholders, maintaining relationships with GRAST members, including GRA Regions and Regulatory CMC.
Qualifications A bachelor’s degree (four‑year university degree) in pharmacy, biology, chemistry, pharmacology, clinical medicine, or a related life science is required. An advanced degree in a related field (MS, PhD, MD, DVM) or MBA is preferred.
10+ years of 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 the 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 one health authority.
About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms—plasma fractionation, recombinant protein technology and cell and gene therapy—to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit
https://www.csl.com/
and CSL Plasma at
https://www.cslplasma.com/ .
Our Benefits For more information on CSL benefits visit
How CSL Supports Your Well‑being .
You Belong at CSL At CSL, inclusion and belonging are at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit
https://www.csl.com/careers/inclusion-and-belonging .
Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit
https://www.csl.com/accessibility-statement .
#J-18808-Ljbffr
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 contribute to the vision and goals of CSL. You will serve as a regulatory leader who leverages regional regulatory experience and expertise to influence and actively contribute to an innovative, scientifically sound, global integrated regulatory vision and strategy for assigned products with a patient‑centric focus. You will apply regional commercial insights and prudent risk‑taking to ensure timely delivery of successful regulatory outcomes.
Effectively partner with the assigned product’s Global Regulatory Affairs Strategy Team (GRAST), GRA, and other regional, labeling and CMC GRAST members to ensure a unified GRA voice, effective inputs into risk assessment and decision‑making, and bi‑directional communication with stationed region commercial operations and GRA.
Directly engage with health authorities (FDA or EMA) in the stationed country, maintaining productive relationships with HA contacts and driving positive regulatory outcomes for assigned products in conjunction with the Global Regulatory Lead. You may also lead product health‑authority interactions with support from the GRL or Regulatory TA Head.
Partner with GRAST members to achieve regulatory deliverables, including leading assigned tasks while fostering accountability, team spirit, and expeditious decision execution that results in positive regulatory outcomes.
Responsibilities
Accountable for the assigned product relationship with a health authority (FDA or EMA), ensuring alignment with the product GRA Lead and, as needed, support from the Head, Regulatory TA in case of escalation. Actively negotiate on behalf of CSL with the health authority to achieve desired outcomes.
Serve as the regional expert on health‑authority requirements, regulatory filing pathways/categories, processes, and ways of working. Provide sound guidance and assessment to internal stakeholders (e.g., GRAST, GRA Lead & Commercial) on how to address project challenges, leverage regulatory opportunities, and advise on risk for developmental, new, and marketed products.
Under the product GRA Lead, lead regional regulatory activities as assigned, including the preparation of core documents (e.g., core briefing book, pediatric plans), product filing preparation activities (investigational, new and marketed), and health‑authority engagements. Responsible for Module 1 documentation required for submission and for leading responses to health‑authority comments with guidance from the GRA Lead.
Actively contribute to GRAST activities, strategy development, document reviews, and competitive regulatory intelligence. Ensure on‑time execution of regulatory activities at the regional level, achieving positive outcomes. Partner with the GRA Lead to develop internal communications and distribute GRA communications to regional commercial stakeholders, maintaining relationships with GRAST members, including GRA Regions and Regulatory CMC.
Qualifications A bachelor’s degree (four‑year university degree) in pharmacy, biology, chemistry, pharmacology, clinical medicine, or a related life science is required. An advanced degree in a related field (MS, PhD, MD, DVM) or MBA is preferred.
10+ years of 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 the 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 one health authority.
About CSL Behring CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms—plasma fractionation, recombinant protein technology and cell and gene therapy—to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people and delivers its lifesaving therapies to people in more than 100 countries.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit
https://www.csl.com/
and CSL Plasma at
https://www.cslplasma.com/ .
Our Benefits For more information on CSL benefits visit
How CSL Supports Your Well‑being .
You Belong at CSL At CSL, inclusion and belonging are at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit
https://www.csl.com/careers/inclusion-and-belonging .
Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit
https://www.csl.com/accessibility-statement .
#J-18808-Ljbffr