Senior Manager Regional Regulatory Affairs
2 weeks ago
CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.
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.
Could you be our next Senior Manager of Regional Regulatory Affairs? This position is located in our King of Prussia PA office. It is a Hybrid role. You will report to the Director, Regional Regulatory TA Lead.
RESPONSIBILITIES:
- You will be the primary CSL representative to regional health authorities for assigned products.
- Develop the establishment and maintenance of high quality relationships with regional health authorities and collaborating with respective GRA Global Regulatory Leads (GRLs) (Global Product Strategy or CMC) and team members to enhance these relationships.
- Contribute to regulatory and account for changes in relevant regulations / laws helping CSL's business within the Region North America and providing regulatory assessment of these changes.
- Assure a productive collaboration with important company partners, such as Regional commercial operations, to ensure successful development, strategic agreement and execution of regional regulatory strategies that result in successful applications for assigned products, from early development to Marketing Authorization (MA), and for any post MA submissions.
- You will contribute regional regulatory perspective to the global regulatory strategy and aligning regional strategies with the global strategy throughout the product lifecycle for assigned products.
- Guide. facilitate comprehensive, commercially and globally aligned regulatory activities within GRA NA for assigned products throughout development and after commercialization.
- Be a GRA NA representative for assigned projects to the Global Regulatory Affairs Strategy Team (GRAST) to provide regional input into the delivery of science-based and globally aligned regulatory strategy with GRL.
Your Experience
- A bachelor's degree in Science or Pharmacy.
- 7+ years of experience in the pharmaceutical industry in Biologics/Research & Development, some experience may be accounted for with advanced degree.
- 3+ years of experience in regulatory, supported by additional pharmaceutical /industry experience. Direct regulatory-facing experience
- Working knowledge of regulatory guidelines and legislative requirements for US FDA regulations.
- Experience in negotiations and facilitating resolution of issues with regulatory agencies and with positive outcomes.
- Driving complex projects throughout a product's lifecycle utilizing broad experience with health authorities or project teams
Benefits
- Medical, Dental, Vision
- 401k
- PTO
CSL 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-
Manager, Regulatory Affairs
4 weeks ago
King of Prussia, Pennsylvania, United States CSL Behring Full timeJob DescriptionCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to...
-
Manager, Regulatory Affairs
1 month ago
King of Prussia, Pennsylvania, United States CSL Behring Full timeJob DescriptionCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to...
-
Lead for Global Regulatory Affairs, Plasma
2 weeks ago
King of Prussia, Pennsylvania, United States CSL Behring Full timeJob Description CSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives. With operations in 35+ nations and 30,000 employees worldwide, CSL is inspired to...
-
Lead for Global Regulatory Affairs, Plasma
2 weeks ago
King of Prussia, Pennsylvania, United States CSL Behring Full timeCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...
-
Regulatory Manager, Advertising
4 weeks ago
King of Prussia, Pennsylvania, United States CSL Behring Full timeCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...
-
Regulatory Manager, Advertising
1 month ago
King of Prussia, Pennsylvania, United States CSL Behring Full timeCSL Behring is a global biotechnology leader, guided by a promise to save and improve lives. Millions of people around the world are living with rare and serious medical conditions. CSL Behring is committed to delivering medicines that improve their lives.With operations in 35+ nations and ~ 30,000 employees worldwide, CSL is inspired to develop and deliver...
-
Senior Manager, Patient Engagement and Advocacy
4 weeks ago
King of Prussia, Pennsylvania, United States CSL Behring Full timeResponsibilities:· Develops strategies and recommendations for improving processes, efficiency and practices.· Fosters effective cross functional relationships including but not limited to Marketing, Medical Affairs, Regulatory Affairs, Legal, Compliance and Sales.· Ensures collaboration between brand marketers and Patient Engagement Associates with...
-
Senior Manager, Patient Engagement and Advocacy
1 month ago
King of Prussia, Pennsylvania, United States CSL Behring Full timeResponsibilities:· Develops strategies and recommendations for improving processes, efficiency and practices.· Fosters effective cross functional relationships including but not limited to Marketing, Medical Affairs, Regulatory Affairs, Legal, Compliance and Sales.· Ensures collaboration between brand marketers and Patient Engagement Associates with...
-
Regional Trainer
1 week ago
King of Prussia, Pennsylvania, United States Allied Universal Full timeJob Description Allied Universal is hiring a Regional Trainer. The Regional Trainer will teach Allied Universal employees at all levels, upskilling employees to develop a safety, service, and growth mindset. Training course development, delivery and compliance-tracking will be conducted in accordance with all federal, state or province, and local laws and...
-
Senior Manager Sales
2 weeks ago
King of Prussia, Pennsylvania, United States ACL Digital Full timeACL Digital, a subsidiary of ALTEN group, a listed company in France with revenues of ~$3.7 billion in 2022, is looking for a Manager / Senior Manager to join their Sales team in their Life Sciences division headquartered in King of Prussia, PA. This is a hybrid position with the expectation of working in the office at least three days/week. We are looking...
-
Manager, Regional Marketing
1 week ago
King of Prussia, Pennsylvania, United States GreenThumb Full timeManager, Regional Marketing (Pennsylvania) The Role The Manager, Regional Marketing drives growth in Pennsylvania through developing, managing, executing, and analyzing regional marketing initiatives. They coordinate with local stakeholders, translating brand objectives into tactical programs. Reporting to the Commercial General Manager, they work closely...
-
Regional Purchasing Manager
2 weeks ago
King of Prussia, Pennsylvania, United States Arkema Full timeThe Arkema Americas Corporate Goods and Services Purchasing team has an opening for a Regional Purchasing Manager (RPM) to be based out of King of Prussia, PA (soon to be Radnor, PA). This position will be responsible for Indirect Purchasing for East Coast and Midwest Gulf Region and other sites as applicable.This individual will have category responsibility...
-
King of Prussia, Pennsylvania, United States GlaxoSmithKline Full timeSite Name: USA - Pennsylvania - King of PrussiaPosted Date: May This is a significant role as part of the Global EHS Team for GSK. You will function as an Industrial Hygiene Subject Matter Expert (SME), helping to set standard for the central organization, and supporting sites, as needed. This focuses on the management of Industrial Hygiene and Ergonomics...
-
King of Prussia, Pennsylvania, United States GlaxoSmithKline Full timeSite Name: USA - Pennsylvania - King of PrussiaPosted Date: May This is a significant role as part of the Global EHS Team for GSK. You will function as an Industrial Hygiene Subject Matter Expert (SME), helping to set standard for the central organization, and supporting sites, as needed. This focuses on the management of Industrial Hygiene and Ergonomics...
-
Regional Manager- Risk
1 week ago
King of Prussia, Pennsylvania, United States UHS Full timeResponsibilitiesAbout Universal Health ServicesUniversal Health Services, Inc. (UHS) is a leading provider of hospital and healthcare services with a strong track record of success. As a Fortune 500 company, UHS had annual revenues of $14.3 billion in 2023 and is consistently recognized for its achievements. Headquartered in King of Prussia, PA, UHS employs...
-
Senior Manager/Associate Director
1 week ago
King of Prussia, Pennsylvania, United States GlaxoSmithKline Full timeSite Name: USA - Pennsylvania - King of Prussia, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper ProvidencePosted Date: Jun 5 2024 The Senior Manager/Associate Director, Biologic Services, Strategic External Development will be a subject matter expert, who has established a deep understanding of the modality of antibody-drug conjugates (ADCs),...
-
Senior Manager/Associate Director
3 weeks ago
King of Prussia, Pennsylvania, United States GlaxoSmithKline Full timeSite Name: USA - Pennsylvania - King of Prussia, USA - Massachusetts - Waltham, USA - Pennsylvania - Upper ProvidencePosted Date: Jun 5 2024 The Senior Manager/Associate Director, Biologic Services, Strategic External Development will be a subject matter expert, who has established a deep understanding of the modality of antibody-drug conjugates (ADCs),...
-
Senior Account Manager
2 weeks ago
King of Prussia, Pennsylvania, United States Arkema Full timeReference #: A1 Sr. Account Manager role is responsible for strategic key account management including our largest regional customer and development for the Commercial Vehicles and the Oil & Gas markets. This role drives the development of key customer relationships to execute business sales growth and earnings strategy. Key product responsibilities include...
-
Regional Director
2 weeks ago
King of Prussia, Pennsylvania, United States UHS Full timeResponsibilities One of the nation's largest and most respected providers of hospital and healthcare services, Universal Health Services, Inc. (UHS) has built an impressive record of achievement and performance. Growing steadily since its inception into an esteemed Fortune 500 corporation, annual revenues were $13.4 billion in 2022. During the year, UHS...
-
Regional Director
1 week ago
King of Prussia, Pennsylvania, United States UHS Full timeResponsibilities One of the nation's largest and most respected providers of hospital and healthcare services, Universal Health Services, Inc. (UHS) has built an impressive record of achievement and performance. Growing steadily since its inception into an esteemed Fortune 500 corporation, annual revenues were $13.4 billion in 2022. During the year, UHS was...