Lead for Global Regulatory Affairs, Plasma

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 CSL Plasma Lead for Global Regulatory Affairs, Plasma? This position is located in our King of Prussia PA, Holly Springs NC, Waltham MA, or Boca Raton office. It is a Hybrid role. You will report to the VP, Head of GRA CMC.

You will provide strategic leadership and oversight in building global regulatory strategies to support CSL Plasma's activities. You will contribute to the vision, goals and improvement of Global Regulatory Affairs and includes collaboration with external (e.g. Health Authorities, Industry Associations) and company partners to shape regulatory CMC requirements.

You will lead and direct strategy for regulatory compliance for all CSL Plasma Inc Operations to include:

o Authorized Official contact e.g., with FDA and other health authorities.

o Serve as a liaison/representative for our submission to regulatory agencies.

o Serve as the primary regulatory interface to relevant global technical expert functions.

o Oversees and interprets relevant our regulatory requirements, evaluates draft guidelines, writes impact assessments, leads gap analysis, and proposes solutions and strategies to remediate risks.

o Provides complete, accurate and timely regulatory strategies, advice, impact assessments and risk mitigation proposals to enable successful regulatory outcomes and facilitate balancing of business objectives and current health authority expectations.

o Provides communications between Global Regulatory Affairs CMC and partners within GRA and across and outside of the organization, as evidenced by the successful achievement of CMC regulatory milestones according to project plans, and by the level of partner satisfaction with the support provided by the group.

o Establish and maintain a group of professionals working in an efficient, productive, and harmonized fashion to be the experts for the assigned product and project portfolio. Ensure approaches and further development of best practices. Selects, develops and evaluates personnel to ensure the efficient operation of the function.

o Builds, mentors and develops a team to support their technical and career development needs. Manage contract staff and vendor to support regulatory activities.

o Manages activities, including resources, budgets, information management systems and planning, following the Global Regulatory Affairs activities. Manage large team with average complexity that led by Managers and Supervisors.

o Provides strategic regulatory guidance to ensure, regulatory strategies are achieved in an aligned and efficient fashion. Ensure they are complete, accurate and consistent with project objectives.

o In collaboration with the GRA Regions, works to resolve regional critical issues concerning global regulatory strategies.

o Ensures adequate regulatory support during HA inspections.

o Accountable for the provision of strategic regulatory advice for complex, critical plasma fractionation changes to the relevant development, quality and manufacturing departments for a fast and efficient approval. This includes the coherent and correct regulatory assessment and the efficient execution of CMC changes, technical changes related to facility and equipment and plasma fractionation changes and where relevant for deviations.

o Represent CSL Plasma as an Authorized Official or responsible person in interactions with regulatory agencies worldwide. Directly partner with regulatory authorities on issues. Maintain a positive relationship with all regulatory officials and respond to all inquiries in a timely fashion. Accompany and negotiate with European and other foreign health authorities during Center and laboratory audits and consult with FDA inspectors. Be a liaison/representative for our submissions to regulatory agencies.

o Ensures productive collaboration with relevant senior leaders, peers and teams globally by providing direction on emerging regulatory trends, regulations and changes, to enable a and planning to future our requirements. Lead regulatory strategies and activities globally – contribute regulatory compliance elements in our mission.

o As a member of the GRA CMC Leadership Team, support the Head GRA CMC in developing regulatory infrastructure to support the function in delivering expected results. Contribute to the development of global regulatory processes for the continued success of the function.

o Participates in outside meetings, forums to ensure the latest thinking is applied to regulatory strategies and acts as subject matter expert. Evaluate draft guidelines and write impact assessments. Provide strategic input to product strategy discussions within GRA. Maintain knowledge of global regulatory requirements, analyze current trends and anticipate changes in the regulatory requirements to adjust strategic plans.

o Directly help develop programs and procedures that exceed the requirements of the regulatory bodies and are designed and implemented to assure maximum efficiency and exceed the expectations of all partners.

Experience

• Degree in Biological Sciences or related health sciences
• 12+ years experience in the pharmaceutical/health care industry, at least 8 years in Global Regulatory Affairs, Biologics Regulatory experience.
• 10+ years leadership experience, including managing regulatory teams
• Global regulatory experience including knowledge of application submission processes and product life cycle management activities
• (CMC) knowledge of the regulatory framework and requirements for product development and lifecycle management in more than one main region (EU, US, Japan, China)
• Experience with plasma collections.

BENEFITS

• Medical, Dental Vision
• 401K
• Paid time Off

#LI-Hybrid

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.

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.

As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.