Director, Sr. Global Regulatory Lead
- Employer
- CSL Behring
- Location
- King of Prussia, Pennsylvania
- Start date
- May 22, 2022
View more
- Discipline
- Regulatory, Regulatory Affairs
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- Pharm Country
Job Details
Primary Activities:
- Regulatory leaders, who craft and drive development of scientifically sound, prospective, global regulatory strategies for a product portfolio, focusing on the patient and applying prudent risk-taking to achieve desired regulatory outcome
- Represent GRA on multi-product Product/Project Strategy Teams (PSTs), Clinical Development Teams (CDTs), Safety Management Teams (SMTs), Evidence Access Strategy Team (EAST) and internal governance meetings (e.g. TPRC/TALT) as the single voice of GRA and lead the Global Regulatory Affairs Strategy Team (GRAST) for respective portfolio.
- As GRAST Leader, leverage the GRAST members to achieve regulatory deliverables (including assign tasks), act as decision maker for team as needed, assess plus communicate regulatory outcomes and fosters review/discussion, plus ultimately approves, project related deliverables (e.g. GRSO, TPP, TPC, Protocol, CCDS, CTD clinically related sections) for the Team.
Accountabilities:
1.Actively contributing as a Full-Time GRA Member for respective product portfolio teams (e.g. PST, CDT, SMT, TMI Project) and articulating sound, regulatory input/perspective into product strategy2.Effectively leading the product portfolio GRASTs, utilizing full GRAST membership, to prudently and expeditiously deliver global regulatory submissions throughout development, including partnering with respective Regulatory Project Manager to ensure on-time delivery.3.Lead GRA project deliverables (e.g. Core Briefing Books, Orphan Drug Designation, Pediatric Study Plans) and mentor GRAST members, as appropriate.4.Facilitate reviews and be respective GRA reviewer signatory for CTD clinical/safety documentation (development/registration).5.Partner and actively support GRA Region in product portfolio health authority interactions globally and participate in overall product/clinical/safety related interactions.6.Ensure bi-directional communication between product (e.g. PST/CDT) and GRA teams (GRAST/GRA TA Team) on product related activities (scientific/business/patient), including driving management communication for GRA activities.7.Leverage GRAST, competitive regulatory intelligence/informatics, business insights / analytics and other specialized regulatory functions (e.g. device/combination products) to deliver Global Regulatory Strategy Outlines for portfolio.Qualifications:
Education: Minimum 4-year university degree (or equivalent) in scientific field (e.g. biology/life sciences, pharmacy, chemistry/biochemistry, engineering/computer sciences, medicine), advanced degree preferred (e.g. PhD, MS, MBA). Experience: 12+years biotech/ pharmaceutical industry, 8 years regulatory experience, including 5 years in development. Direct agency interaction experience, preferably ICH regions. Team leadership experience, preferably 5 years as direct or matrix manager. Clinical (or Device/Combination Product) regulatory experience preferred. Exposure to market access activities is preferred. Competencies: Strong scientific and ethical foundation. Consistently applies Servant Leadership and Team Player principles to team environment, including leading without authority. Strategic ability to assess product vision and apply regulatory lens to effectively articulate regulatory assumptions, opportunities, and risks. Builds and works effectively across cultures, inclusive and seeks out alternative perspectives when assessing potential outcomes. Prior experience mentoring junior staff members in regulatory affairs. Fluent in English (written & verbal). About UsOur Benefits
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.
Do work that matters at CSL Behring!
Company
As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research.
CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential.
CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries.
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!
Stock Symbol: CSL
Stock Exchange: Australian Securities Exchange
- Phone
- 610-878-4000
- Location
-
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States
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