Senior Pharmaceutical Affairs manager
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Job Location:
Monthly Salary:
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
Do you want to work in a motivating supportive environment where you help patients across the world get access to life-saving medicine If so we want to hear from you.
Korn Ferry is supporting Clinigen in their search for a Senior Pharmaceutical Affairs manager to be based in their Lyon office. This is a hybrid role LEMS Grade 6B with some international travel opportunities.
As senior Pharmaceutical Affairs manager youll be responsible for ensuring regulatory compliance pharmaceutical quality and the smooth operation of the sites activities.
This is a strategic role that contributes to the success of Clinigens clients licensed products.
What you will be responsible for -
Management of MA and regulatory activities
- Monitoring of French regulatory activities
- Management of packaging items
- Regulatory review of promotional/environmental /institutional documents
- Preparation of QTA and SDEA
- Management of PQC and packaging items
Quality assurance activities
- Site document management system: writing and updating internal procedures document distribution
- Participation Implementation and follow-up of CAPA and change control audits and audit control. Follow-up of non-conformities deviations complaints.
- Monitoring subcontractors/service providers
- Participating in Product Quality Reviews and writing Shortage Management Plans
Pharmacovigilance and Medical Information
- Collection and routing of vigilance reports and requests for medical information
- Monitoring the proper use of medicines and assessing the medicinal risks
Early Market Access support within other regions.
- Meetings with clients and preparation of proposals
- Submission of applications and follow-up
- Management of periodic reports and management of real-life data
- Preparation of QTA and SDEA
- Coordination with all internal stakeholders and the client
About You
- Qualified pharmacist (registered or eligible for registration with the French Order of Pharmacists Section B).
- Confirmed experience (10 years) in a similar role within an operational site.
- Strong knowledge of French and EU regulatory frameworks (MAs early access pharmacovigilance quality).
- Proven experience in project management and client relationship handling.
- Established experience in communicating with the ANSM including agency meetings
- Solid expertise in quality assurance and audit management.
- Ideally with RA experience such as clinical trial submissions briefing documents MAAs post marketing maintenance
- Fluent English & French (spoken and written).
Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses operating in complex global regulatory environments to ensure that vital medicines are delivered securely on time and wherever they are needed in the world.
Join Clinigen to help to make that vision a reality.
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Korn Ferry is a global organizational consulting firm. We work with our clients to design optimal organization structures, roles, and responsibilities. We help them hire the right people and advise them on how to reward and motivate their workforce while developing professionals as th ... View more
