New · posted Nov 5
CSL · Biotechnology
Director, Senior Global Regulatory Lead
- King of Prussia, PA
- Hybrid
- Full-time
- Director
The role
The Director, Senior Global Regulatory Lead (Sr. GRL) is a key member of CSL’s Global Regulatory Strategy (GRS) organization and serves as the global regulatory leader for assigned products within the respective therapeutic area.
In this highly visible, strategic role, you will develop and lead innovative, science-driven global regulatory strategies across the product lifecycle, from early development through registration and post-marketing activities. You will serve as the primary Global Regulatory Affairs (GRA) representative on Product Strategy Teams (PSTs) and other cross-functional development teams, ensuring regulatory strategies are integrated into product development decisions and aligned with broader business objectives.
As a trusted regulatory partner, you will build and maintain productive relationships with global health authorities, particularly the FDA and EMA, while guiding regulatory teams through complex development and approval pathways. You will influence strategic decisions, anticipate regulatory challenges, and identify opportunities to accelerate the delivery of innovative therapies to patients.
Depending on the role, you may also lead and develop Regional Regulatory Leads, fostering a collaborative, accountable, and high-performing global team.
Director, Senior Global Regulatory Lead (Sr. GRL)
Global Regulatory Strategy (GRS)
What you need
Education
- Bachelor's degree in Pharmacy, Biology, Chemistry, Pharmacology, Clinical Medicine, or a related life science discipline required.
- Advanced degree (MS, PhD, MD, DVM) or MBA preferred.
Experience
- Minimum of 10 years of experience in the biotechnology or pharmaceutical industry, including at least 8 years in Regulatory Affairs.
- At least 5 years of experience supporting pharmaceutical or biological product development.
- Demonstrated experience leading teams, preferably with 5 years of direct or matrix leadership experience, including setting strategic direction, driving accountability, and developing talent.
- Strong knowledge of pharmaceutical and biological product development and regulatory requirements across multiple major regions, including the US, EU, and/or Japan.
- Demonstrated experience working directly with at least one major health authority, such as the FDA or EMA.
- Experience navigating complex, global, matrixed organizations and influencing cross-functional stakeholders.
- Strong clinical development or medical device expertise is highly desirable.
Leadership & Competencies
The successful candidate will bring:
- Strong strategic thinking and the ability to translate complex regulatory considerations into actionable development strategies.
- Excellent communication, influencing, and relationship-building skills, including the ability to engage effectively with senior leadership and health authorities.
- Sound judgment and confidence in making complex regulatory decisions and taking calculated risks.
- The ability to lead through influence, foster collaboration, and drive accountability across geographically dispersed teams.
- A patient-focused mindset and passion for advancing innovative therapies through successful development and approval.
The expected base salary range for this position at hiring is $242,000 - $270,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the time of this posting in MA. 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.
What you'll do
- Develop Global Regulatory Strategy: Establish and lead integrated, science-based global regulatory strategies for assigned products, supporting development, registration, and post-marketing lifecycle activities while balancing innovation, patient needs, and business priorities.
- Lead Cross-Functional Regulatory Partnership: Serve as the primary GRA representative on Product Strategy Teams and partner with Clinical Development, Safety, Commercial, Research, and other key stakeholders to ensure regulatory considerations are incorporated into product strategy and decision-making.
- Drive Health Authority Engagement: Lead strategic relationships and interactions with key health authorities, including the FDA and EMA, and collaborate with regional regulatory partners to support successful regulatory outcomes across global markets.
- Provide Regulatory Leadership and Oversight: Lead the Global Regulatory Affairs Strategy Team (GRAST) for assigned products, establishing priorities, coordinating deliverables, assigning responsibilities, and ensuring alignment across global regulatory functions.
- Influence Product Development Decisions: Serve as the primary GRA reviewer and, where appropriate, approver of key development deliverables, including protocols, Target Product Profiles (TPPs), and other strategic documents. Provide regulatory guidance to senior leadership and cross-functional teams.
- Lead Strategic Regulatory Deliverables: Oversee the development of key regulatory documents and initiatives, including Core Briefing Books, Orphan Drug Designations, Pediatric Study Plans, and Global Regulatory Strategy Outlines.
- Drive Regulatory Intelligence and Innovation: Leverage competitive regulatory intelligence, emerging technologies, AI-enabled insights, business analytics, and specialized regulatory expertise to inform strategy, assess opportunities, and proactively address potential challenges.
- Promote Global Regulatory Alignment: Build strong relationships across Global Regulatory Strategy, including regional regulatory teams and Regulatory CMC, to promote consistency, knowledge sharing, and a unified global regulatory approach.
- Lead and Develop Talent (where applicable): Coach and develop Regional Regulatory Leads, establish clear performance expectations, foster accountability, and support succession planning and career growth.
- Champion CSL Leadership Capabilities: Demonstrate CSL's leadership capabilities by building partnerships, thinking strategically, driving outcomes, embracing agility, inspiring innovation, and cultivating talent.
Pay
$242,000 – $270,000 a year
Employer providedFor more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
Where you'll work
King of Prussia, PAHybridOpen in Maps (opens in a new tab)
More jobs in King of Prussia, PA
From the posting
About CSL
CSL’s R&D organization is accelerating innovation to deliver greater impact for patients. With a project-led structure and a strong focus on collaboration, we’re building a future-ready organization that thrives in dynamic biotech ecosystems. Join CSL and become part of an agile team committed to developing therapies that make a meaningful difference for patients around the world.
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 of 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/.
You Belong at CSL
At CSL, Inclusion and Belonging is 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, accessibility and legal noticesCSL's statements, word for word
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.
Job intelligence
The context around this role
Live data · November 5, 2026
Salary intelligence
How the pay compares
This role's midpoint is 1% above the US median for Regulatory Strategy roles at this level.
This roleEmployer provided
Director roles in the US43 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| This role | $242,000 | — | $270,000 |
| All US (middle half) | $227,500 | $253,500 | $265,750 |
This role: CSL's own published range. Comparisons: the base pay employers published on open Regulatory Strategy roles at the same level on Regulatory Jobs, November 5, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Regulatory Strategy
The general path across 83 open Regulatory Strategy roles on Regulatory Jobs, with the titles they carry most. Not CSL's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 31 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Collaboration and leadership17
- Regulatory submissions9
- Clinical trial conduct3
- Documentation and SOPs2
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Regulatory Strategy work in biotechnology, each linked to the agency or standards body that publishes it.
- FDAFDA expedited programs(official source, opens in a new tab)Fast track, breakthrough therapy, accelerated approval and priority review
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 314(official source, opens in a new tab)Applications for FDA approval to market a new drug (NDA and ANDA)
- FDA21 CFR Part 601(official source, opens in a new tab)Licensing of biological products and changes to an approved BLA
- EUDirective 2001/83/EC(official source, opens in a new tab)The EU code for medicinal products for human use: authorization, labeling, pharmacovigilance
- PMDAJapan PMDA(official source, opens in a new tab)Japan's Pharmaceuticals and Medical Devices Agency
- ICHICH M4 (CTD)(official source, opens in a new tab)The Common Technical Document: how a registration dossier is organized
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- FDA21 CFR Part 201(official source, opens in a new tab)FDA labeling requirements for drugs, including prescribing information
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trials
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- FDA21 CFR 314.70(official source, opens in a new tab)Supplements and other changes to an approved application (post-approval CMC changes)
- EURegulation (EC) 1234/2008(official source, opens in a new tab)EU variations to the terms of a marketing authorization
- FDA21 CFR Part 1271(official source, opens in a new tab)Human cells, tissues, and cellular and tissue-based products
- MHRAUK MHRA(official source, opens in a new tab)The UK regulator of medicines and medical devices, including UKCA marking
From Regulatory News
Manufacturing and quality coverage for this professionCompany hiring pulse
CSL on Regulatory Jobs
- 25
- Open roles
- 25
- Distinct roles
- 4
- Locations
By discipline
- Clinical13 52%
- Regulatory6 24%
- Quality6 24%
By level
- Senior & Principal10 40%
- Director8 32%
- Manager4 16%
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Director, Senior Global Regulatory Lead at CSL
Open until filled. $242K–$270K a year, employer provided.