Position purpose
Local Regulatory Responsible (LRR) oversees Local Regulatory Support (LRS) role to ensure effective decision making and smooth operations and acts as the first escalation point for LRS challenges.
LRR focuses on local regulatory requirements and Health Authority (HA) national engagements.
The key interactions are with local external stakeholders e.g. Health Authorities, Local industry association(s), In Market commercial counterpart and Regional Regulatory Lead (RRL) counterparts in respective GRAS Regional team
Leadership
Supervises LRS(s) within the same country to encourage strong decision-making and facilitate smooth daily operations
Act as (local, first) escalation point for any challenges arising amongst LRR/LRS teams and (if required) effectively escalating those challenges to the respective Director RA/PV Cluster Head
Strategy (execution) & management
Provide local inputs to develop and execute innovative regulatory strategies for new product registrations and lifecycle management activities; monitor and report progress consistently to stakeholders
Ensure strict compliance with local regulations, actively participating in policy activities with industry groups and trade associations. Act as Regulatory Affairs (RA) representative in audit/inspection and ensure readiness and timely CAPA closure in alignment with other functions
Strategy (execution) & management
Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulation and subsequently communicate requirements to GRAS and local staff; participate actively in regulatory meetings, forums, and conferences to stay informed share insights and best practices within the organization
RA support and stakeholder engagement
Act as primary interface with local HAs, industry groups, and trade associations, representing the company's regulatory interests and fostering positive relationships; lead in-country regulatory processes, acting as the final contact point with HAs for licenses, partner regulatory licenses, and market access collaborations
Prepare, organize and coordinate local specific documentation e.g. module 1 to meet national submission requirements and be responsible for keeping up-to-date local national systems as per local legislation
Provide critical support for implementation of local legislation, promotional material review, interpretation of regulations and regulatory agency expectations as well as lead regulatory strategies for product launches and integrations at affiliate level
Support regional regulatory TA teams within GRAS, for efficient planning and submission preparation according to local requirements and business needs; monitor status of submitted regulatory activities with local health authorities
Act as primary RA representative for local ComOps: adopt a business perspective, explore opportunities and translate this thinking into actionable plans that fit with strategy
Keep RIMS up to date with local activity and ensure compliance KPIs are adequately kept on track
Ensure compliant labeling (SmPC, PIL, packaging) and manage timely updates including translation, and promotional material review
Profile requirements:
Relevant bachelor’s degree or equivalent secondary education e.g. natural sciences (biology, chemistry with pharmacological focus)
Advanced degree (Master’s or PhD) preferred in e.g., law, legal affairs, natural sciences (biology, chemistry with pharmacological focus)
5+ years of (local) regulatory knowledge and experience in a regulatory authority facing role; i.e. comprehensive understanding of regional and global regulatory requirements, guidelines and processes
Leadership experience
In-depth expertise on local health authority management
Project management skills and leadership skills; i.e. proven experience in managing e.g. regulatory submissions, timelines and cross-functional teams to ensure timely and successful product registrations and compliance
Experience in managing ComOps Stakeholders: matching influencing style to stakeholders to maximise impact and effectiveness of GRAS expertise, proactively identifying opportunities to influence stakeholders on business critical decisions and employing a systematic approach to influence key internal stakeholders based on business needs and objectives
Experience in successfully dealing with rapid change
Fluent in Turkish and English, oral and written
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/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
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 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.
