We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Manager, Promotional materials
Responsible for the management of Regulatory Affairs and Development Consulting and Science projects requiring specific scientific experience and skills in the health products sector in line with the requirements of European regulations.
Focus on review of promotional and non-promotional materials.
- Review of promotional and non-promotional materials, for medicines and medical devices
- Consultancy on “AdPromo”
- Deliver training courses on “AdPromo”
- Ensure and organise the formatting, submission and follow-up of files submitted to national and European authorities
- Ensure that deadlines and the quality of the files given to clients are respected
- Prepare and submit CTAs
- Write briefing documents
- Regulatory consultancy on miscellaneous topics in consultation with senior management
- Ensure that the dossiers are processed in accordance with the regulations in force and in compliance with the commitments made to clients
- Manage readability tests and bridging reports
- Manage European regulatory projects (task coordination, budget follow-up, partners management, knowledge sharing…)
- Establish the list of documents necessary for the constitution of the dossiers
- Document analysis and evaluation
- Regulatory writing
- Constitution and formatting of dossiers
- Participate in working meetings with clients: defining a problem, solving it
- Participate in audits or diagnosis of dossiers
- Maintain his level of knowledge in line with changes in regulations, national and Community registration requirements
- Make a regulatory monitoring adapted to its activity
- Define its specific documentary needs
- Submit European dossiers in eCTD format (CP, MRP/DCP, renewals)
- Manage parallel import activities
- Manage packaging and labelling activities
- Comply with quality procedures
- Prepare proposals and budgets (PCT)
- Draft and coordinate answer to RFP
- Successful completion of Pharmacist’s diploma possibly completed by a Master’s degree in Regulatory Affairs
- 2 to 3 years of professional experience and project management experience
- Knowledge of French and European regulatory requirements for medicinal products
- Experience with review of promotional and non-promotional materials
- Distinctly strong service orientation
- Content-related experience in several relevant areas of Regulatory Affairs
- Ability to manage one or several activities with limited guidance
- Independent approach to work, flexibility and dedication
- Diplomacy, ability to communicate and integrate in an international and multicultural environment
- Strong sense of responsibility, organizational skills and intrinsic motivation
- French and English language fluency, written and spoken
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
Agencies only by prior agreement for the specific job opportunity.