Join Our Team as a Regulatory Affairs Labelling Expert!

Are you ready to make a global impact in healthcare Were seeking passionate and experienced professionals to join our dynamic team in the field of regulatory affairs and labelling. If youre looking for a challenging and rewarding career this is your chance to contribute to innovative projects that improve lives worldwide.

Key Responsibilities

• Participation in the preparation and revision and compilation of the informative texts for healthcare professionals and patients (SmPC PIL Labelling) in EU and also for non-EU markets preferably including development of target product/labelling profiles
• Manages creation and maintenance of CCDS/CCSI/RSI as applicable in direct collaboration with relevant departments/expert functions responsible for CCDS section content (e.g. from medical safety department)
• Ensures communication to internal / external stakeholders regarding new and updated CCDSs and Product Information
• Escalates deviation and compliance issues to the labelling governance bodies (e.g. Safety monitoring committee Global labelling boards) as necessary
• Experience in labelling documentation and informative texts for innovator drugs on a global (headquarter) level
• Planning and expediting the approval projects using the internally available or client-based software tools including databases and document management systems
• Providing regulatory expertise to regulatory programs and projects as well as to clients
• General guidance (consultancy) of Cencora staff and customers regarding Regulatory Submissions & Labelling activities including also updates on new trends and/or changes in legislation
• Creation revision editing and maintenance of regulatory documentation
• Professional interaction with clients and Health Authorities
• Coordination of project teams with internal / external staff and Regulatory Partners on a world-wide level
• Participation in strategic regulatory issues incl. definition of suitable methods of resolution

What You Bring

• Language Proficiency:Fluent business English (or native English) with additional EU language skills as a plus.
• Educational Background:A degree in pharmacy medicine life sciences or a bachelors degree in science
• Regulatory Affairs Expertise:Proven experience in regulatory affairs with a strong track record in labelling activities for innovator drugs on a global level.
• Lifecycle Management:Experience in handling marketing authorizations and their lifecycle management.
• Regulatory Knowledge:Sound understanding of pharmaceutical and regulatory requirements in the EU and ideally in one ICH region.
• Technical Skills:Affinity for databases labelling software tools and project management software with the ability to monitor and adhere to timelines.
• Personal Attributes:Team player with excellent communication skills conscientious accurate and responsible.
• Software Proficiency:Confident in using MS Excel MS Word databases and document management systems .
• Drive Effective Communication:Ensure timely updates and communication regarding new and revised CCDSs and Product Information to internal and external stakeholders.
• Ensure Compliance:Escalate deviations and compliance issues to labelling governance bodies such as safety monitoring committees and global labelling boards.
• Regulatory Expertise:Provide expert regulatory guidance to programs projects and clients while staying ahead of new trends and legislative changes.
• Collaborate Globally:Coordinate project teams with internal/external staff and regulatory partners worldwide ensuring seamless execution and adherence to timelines.
• Client and Authority Interaction:Build professional relationships with clients and health authorities ensuring effective communication and collaboration.

.

Why Join Us

• Be part of a forward-thinking organization that values innovation and excellence.
• Work on impactful projects that shape the future of healthcare.
• Collaborate with a diverse global team of professionals.
• Enjoy opportunities for professional growth and development.
• Make a difference in patients lives through your expertise.

Please note this role is to act as an individual contributor not to manage a team. This role is a remote position.

If youre ready to take your career to the next level and thrive in a challenging yet rewarding environment we want to hear from you! Apply now and become a vital part of our mission to improve healthcare worldwide.

What Cencora offers

Benefit offerings outside the US may vary by country and will be aligned to local market practice. The eligibility and effective date may differ for some benefits and for team members covered under collective bargaining agreements.

Affiliated Companies

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race color religion sex sexual orientation gender identity genetic information national origin age disability veteran status or membership in any other class protected by federal state or local law.

The companys continued success depends on the full and effective utilization of qualified individuals. Therefore harassment is prohibited and all matters related to recruiting training compensation benefits promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned