CSL Behring
With operations in 35
nations and 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza.
Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor.
CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.
Are you the next Director, Senior Global Regulatory Lead for Seqirus? The role can be located in Waltham MA, Holly Springs NC, Zurich Switzerland.
King of Prussia PA or Maidenhead UK.
It is a hybrid role.
You will report to the Senior Director of Regulatory TA Lead.
You will be a member of a GRA GPS Therapeutic Area - Vaccines and contributes to the vision and goals for Global Regulatory Affairs (GRA) as:
Regulatory leaders, who build development of, scientifically sound, prospective, global regulatory strategies for product/s, focusing on the patient and applying prudent risk-taking to achieve desired regulatory outcome.
GRA Representatives on Product/Project Strategy Teams (PSTs), main Delivery Teams (e.
g.
, Clinical Development Teams CDTs , Safety Management Teams SMTs , Evidence Access Strategy Team EAST ), and internal governance meetings as the single voice of GRA and lead the Global Regulatory Affairs Strategy Team (GRAST) for respective product/s.
GRAST Leaders, engage GRAST members to achieve regulatory deliverables (including assign tasks) while fostering individual accountability and 'team spirit', guide understanding, mentor and cultivate talent of members, act for Team, assess and communicate regulatory outcomes, encourage review/discussion, and contribute to or approve project-related deliverables (e.
g.
GRSO, TPP, TPC, CCDS, Protocol, CTD clinically-related sections, education and influence Regulatory Intelligence/Policy) for the Team.
MAIN RESPONSIBILITIES1)You will contribute and build relationships, as a Full-Time GRA Member, for respective product portfolio teams (e.
g.
, PST, CDT, SMT, Incubator Project) and articulating sound, regulatory input/perspective into product strategy.
2) Lead the product portfolio GRASTs, utilizing full GRAST membership and 'One GRA' voice, to prudently and expeditiously deliver global regulatory submissions throughout development, including partnering with respective Regulatory Project Manager.
3) Lead GRA project deliverables (e.
g.
, Core Briefing Books, Orphan Drug Designation, Pediatric Study Plans) and mentor GRAST members.
4) Facilitate reviews and be respective GRA reviewer signatory for CTD clinical/safety documentation (development/registration) as applicable.
5) Partner with GRA Region in product portfolio health authority interactions globally and participate in overall product/clinical/safety related interactions for portfolio.
6) Use GRAST, informatics, business analytics and other specialized regulatory functions (e.
g.
, device/combination products) to deliver Global Regulatory Strategy Outlines for portfolio.
QUALIFICATIONS4-year university degree (or equivalent) in scientific field (e.
g.
, biology/life sciences, pharmacy, chemistry/biochemistry, engineering/computer sciences, medicine)12
years biotech/pharmaceutical industry, with 8
years regulatory experience, including 5 years in development.
Direct agency interaction experience ICH regions, and exposure across multiple ICH health authorities.
Team leadership experience, 5
years as direct or matrix manager.
Clinical (or Device/Combination Product) regulatory experienceExposure to market access activitiesBENEFITSMedical, Dental Vision401KPaid time Off#LI-HybridOur BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1.
We are committed to the wellbeing of our employees and their loved ones.
CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters.
Our benefits are designed to support the needs of our employees at every stage of their life.
Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL BehringCSL 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 usAs a global organization with employees in 35
countries, CSL embraces diversity and inclusion.
Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!About the Company:
CSL Behring.
Estimated Salary: $20 to $28 per hour based on qualifications.
nations and 30,000 employees worldwide, CSL is inspired to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza.
Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.
CSL is the parent company of CSL Behring, CSL Plasma, CSL Seqirus and CSL Vifor.
CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions.
Are you the next Director, Senior Global Regulatory Lead for Seqirus? The role can be located in Waltham MA, Holly Springs NC, Zurich Switzerland.
King of Prussia PA or Maidenhead UK.
It is a hybrid role.
You will report to the Senior Director of Regulatory TA Lead.
You will be a member of a GRA GPS Therapeutic Area - Vaccines and contributes to the vision and goals for Global Regulatory Affairs (GRA) as:
Regulatory leaders, who build development of, scientifically sound, prospective, global regulatory strategies for product/s, focusing on the patient and applying prudent risk-taking to achieve desired regulatory outcome.
GRA Representatives on Product/Project Strategy Teams (PSTs), main Delivery Teams (e.
g.
, Clinical Development Teams CDTs , Safety Management Teams SMTs , Evidence Access Strategy Team EAST ), and internal governance meetings as the single voice of GRA and lead the Global Regulatory Affairs Strategy Team (GRAST) for respective product/s.
GRAST Leaders, engage GRAST members to achieve regulatory deliverables (including assign tasks) while fostering individual accountability and 'team spirit', guide understanding, mentor and cultivate talent of members, act for Team, assess and communicate regulatory outcomes, encourage review/discussion, and contribute to or approve project-related deliverables (e.
g.
GRSO, TPP, TPC, CCDS, Protocol, CTD clinically-related sections, education and influence Regulatory Intelligence/Policy) for the Team.
MAIN RESPONSIBILITIES1)You will contribute and build relationships, as a Full-Time GRA Member, for respective product portfolio teams (e.
g.
, PST, CDT, SMT, Incubator Project) and articulating sound, regulatory input/perspective into product strategy.
2) Lead the product portfolio GRASTs, utilizing full GRAST membership and 'One GRA' voice, to prudently and expeditiously deliver global regulatory submissions throughout development, including partnering with respective Regulatory Project Manager.
3) Lead GRA project deliverables (e.
g.
, Core Briefing Books, Orphan Drug Designation, Pediatric Study Plans) and mentor GRAST members.
4) Facilitate reviews and be respective GRA reviewer signatory for CTD clinical/safety documentation (development/registration) as applicable.
5) Partner with GRA Region in product portfolio health authority interactions globally and participate in overall product/clinical/safety related interactions for portfolio.
6) Use GRAST, informatics, business analytics and other specialized regulatory functions (e.
g.
, device/combination products) to deliver Global Regulatory Strategy Outlines for portfolio.
QUALIFICATIONS4-year university degree (or equivalent) in scientific field (e.
g.
, biology/life sciences, pharmacy, chemistry/biochemistry, engineering/computer sciences, medicine)12
years biotech/pharmaceutical industry, with 8
years regulatory experience, including 5 years in development.
Direct agency interaction experience ICH regions, and exposure across multiple ICH health authorities.
Team leadership experience, 5
years as direct or matrix manager.
Clinical (or Device/Combination Product) regulatory experienceExposure to market access activitiesBENEFITSMedical, Dental Vision401KPaid time Off#LI-HybridOur BenefitsCSL employees that work at least 30 hours per week are eligible for benefits effective day 1.
We are committed to the wellbeing of our employees and their loved ones.
CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters.
Our benefits are designed to support the needs of our employees at every stage of their life.
Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what's available to you as a CSL employee.
About CSL BehringCSL 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 usAs a global organization with employees in 35
countries, CSL embraces diversity and inclusion.
Learn more about Diversity & Inclusion at CSL.
Do work that matters at CSL Behring!About the Company:
CSL Behring.
Estimated Salary: $20 to $28 per hour based on qualifications.
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