Regulatory Compliance Specialist
il y a 4 semaines
Summary
Reporting directly to the Director of Pharmaceutical Affairs, the Regulatory Affairs Associate plays a crucial role in supporting all functions related to pharmaceutical regulations, compliance, pharmacovigilance, and quality management in alignment with Incyte's operational standards and applicable local and European regulations.
Duties and Responsibilities
The role encompasses the management of regulatory functions specific to an Exploitant entity for the products distributed by Incyte Biosciences France:
- Overseeing and validating communication documents: ensuring regulatory compliance, submission to relevant authorities, and effective document management.
- Tracking regulatory activities: managing translations, packaging, and legal notifications.
- Monitoring ongoing projects in collaboration with Corporate Europe.
Additionally, the Associate will engage in various activities within the Pharmaceutical Affairs Department, particularly:
- Coordinating with the EU Supply Chain department to oversee the distribution of pharmaceutical products in France.
- Contributing to the training initiatives for Incyte Biosciences France personnel.
- Participating in pharmacovigilance efforts alongside the Local Qualified Person for Pharmacovigilance (QPPV).
- Engaging in other missions related to current projects as required.
Requirements
- Pharmacy degree or equivalent, eligible for registration in section B of the Order of Pharmacists.
- Proven experience in pharmaceutical affairs within an Exploitant context.
- Strong problem-solving abilities with a solution-oriented mindset.
- Exceptional communication skills.
- Ability to handle sensitive information with discretion.
- Highly organized and dependable.
- Capability to meet deadlines consistently.
- Proficient in Office software applications (Excel, Word, PowerPoint) and Outlook.
- Fluency in French and proficiency in scientific and technical English are mandatory.
Disclaimer: The above descriptions are intended to convey the general nature and level of work performed by employees in this position. They are not exhaustive lists of all duties, responsibilities, and qualifications. Management reserves the right to modify such duties as necessary.
Privacy Notice: Incyte values your privacy and processes your personal data to manage your job application. You may have rights regarding your personal data, including access, deletion, and objection to its use. For more information on Incyte's data protection practices, please refer to our privacy policy.
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