The position available is for a Manager within the Global Regulatory Affairs (GRA) department at CSL. This role focuses on the execution and management of regulatory strategies specifically tailored for the region of Israel. As part of a leading global biotechnology company, this position promises to be integral in the lifecycle management activities of new product registrations.
Key Responsibilities
The Manager will have several critical responsibilities that fall under two main categories: strategy execution and management as well as regulatory support and stakeholder engagement.
Strategy Execution & Management
Provide local inputs to develop and execute innovative regulatory strategies. This includes ensuring that regulatory compliance is strictly adhered to when it comes to product registrations.
Monitor progress and report findings consistently to stakeholders. This ensures transparency and accountability within the regulatory process.
Participate actively in policy activities while collaborating with industry groups and trade associations.
Act as the Regulatory Affairs (RA) representative during audits and inspections, ensuring readiness and timely corrective actions are taken.
Stay updated on local regulations and industry trends to communicate evolving requirements to relevant stakeholders within CSL.
Prepare and organize local documentation needed for national submissions according to local legislation, keeping their systems updated as required.
Regulatory Support & Stakeholder Engagement
Serve as the primary interface with local Health Authorities (HAs) and trade associations, representing CSL's regulatory interests.
Lead in-country regulatory processes, acting as the focal point for licenses and collaborative initiatives for market access.
Implement local legislative support and review promotional materials in adherence to regulations and expectations from regulatory agencies.
Engage with regional regulatory teams to support efficient planning and submission according to local needs, while also tracking submitted regulatory activities closely.
Maintain compliance Key Performance Indicators (KPIs) concerning local activities and ensure accurate labeling updates.
Required Skills
Qualifications for the ideal candidate include:
A relevant bachelor’s degree, ideally in natural sciences (such as biology or chemistry). An advanced degree (Master’s or PhD) is preferred.
3-5+ years of regulatory knowledge and experience, particularly in an authority-facing role.
Strong project management and leadership skills that showcase an ability to manage regulatory submissions, timelines, and cross-functional teams effectively.
Familiarity with regulatory requirements and guidelines both regionally and globally is important. Additionally, certifications such as Regulatory Affairs Certification (RAC) or similar may be desired.
Salary and Benefits
While specific salary details are not provided in the job summary, candidates may expect a competitive compensation package in line with regulatory positions within biotechnology. Additionally, CSL emphasizes that they encourage employees to prioritize their well-being, suggesting that the company likely offers a comprehensive benefits package.
Company Overview
CSL is a recognized global biotechnology company known for innovation in life-saving treatments, with a history dating back to 1916. The company focuses on a broad array of crucial products, including treatments for haemophilia and immune deficiencies, as well as vaccines offering protection against influenza.
The organization strives to reflect diversity and inclusion, advocating for a workplace culture that appreciates differences and provides a dynamic environment for employees.
Employees at CSL are encouraged to immerse themselves in work that matters while contributing to a significant cause within the healthcare sector.
Conclusion
This position as Manager in GRA at CSL combines significant regulatory responsibilities with opportunities for personal and professional growth. The suitable candidate should possess a strong background in regulatory affairs, leadership capabilities, and a passion for contributing to the healthcare industry. If you align with this set of skills and are dedicated to making a difference in healthcare, this could be a remarkable career opportunity.
This job offer was originally published on himalayas.app
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