Senior Regulatory Labelling Specialist
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Ballerup
Are you passionate about life cycle management activities to maintain patient friendly and competitive labels?
Are you motivated by the opportunity to work in cross-functional teams and drive strategies for product information to authorities, health care professionals, payers and patients? Do you have experience with clinical development or with driving labelling strategies globally? Are you a team player? Then we might have the right job for you.
The job
You will be responsible for driving the global labelling strategy for one or several of our marketed products, ensuring alignment with the global regulatory and commercial strategies.
Your primary tasks will be to:
- Lead the Labelling Management Team (LMT) ensuring that the optimal outcome of life cycle management activities are included in the Company Core Datasheet (CCDS).
- Maintain the US PI, the US patient information sheet, the EU SmPC and EU PIL, as applicable, and in accordance with product strategies.
- Provide guidance and support on labelling activities globally, including safety variations, to ensure optimal labels and GxP compliance.
- Represent labelling in Global Regulatory teams and Global Regulatory Affairs in relevant project teams, e.g. safety management teams.
- Act as a key stakeholder during labelling negotiations with regulatory authorities.
- Collaborate with our Global Partner and actively contribute to process optimisation, as relevant.
Your qualifications
You have a Master’s degree or bachelor within science e.g. pharmaceutics, biomedicine, chemical engineer or a related field, and experience within the regulatory or clinical development area (5years).
The ideal candidate is curious, proactive, and eager to learn. Collaborative team-player with strong project management skills, problem-solving, and communication skills are highly valued in this globally focused role.
Your new department
You will be part of a department of dedicated labelling specialists. Our vision is to be strong strategic labelling partners throughout the life-cycle of our products. We are on a journey - and you will be part of a department where we learn together and support each other.
Contact and application
If you have any questions, please do not hesitate to contact Merete Pedersen (Head of Labelling Strategy (+45 22700866), Global Regulatory Affairs.
Information og data
Denne ledige stilling har jobtypen "Øvrige", og befinder sig i kategorien "Øvrige stillinger".
Arbejdsstedet er beliggende i Ballerup.
Jobbet er oprettet på vores service den 26.3.2021, men kan have været deaktiveret og genaktiveret igen.
Dagligt opdateret: Dette job opdateres dagligt ud fra jobudbyderens hjemmeside via vores søgemaskineteknologi og er aktivt lige nu.
- Øvrige
- Ballerup
- Torsdag den 06. maj 2021
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