Our team members are at the heart of everything we do. At Cencora, we are united in our responsibility to create healthier futures, and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health, come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!
Join Our Team as a Regulatory Affairs Labelling Expert!
Are you ready to make a global impact in healthcare? We're seeking passionate and experienced professionals to join our dynamic team in the field of regulatory affairs and labelling. If you're looking for a challenging and rewarding career, this is your chance to contribute to innovative projects that improve lives worldwide.
Key Responsibilities
Shape the Future of Healthcare Communication: Participate in the preparation, revision, and compilation of informative texts for healthcare professionals and patients, including SmPC, PIL, and labelling for EU and non-EU markets. Leverage your expertise to develop target product/labelling profiles.
Lead Global Labelling Initiatives: Manage the creation and maintenance of CCDS/CCSI/RSI in collaboration with cross-functional teams, including medical and safety departments.
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 bachelor’s degree in science, engineering, or mathematics.
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 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.
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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.
If you're 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.
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.
Full timeCencora 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 company’s 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 hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned