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.
Senior Manager Regulatory Affairs
Accountability for the management of projects in the field of Regulatory Affairs that requires established experience and specific scientific expertise in the sector of medicinal and biotech products with special emphasis on the relevant French and European regulations
Active contribution to the consulting activity
Active contribution to the development of the regulatory activities in France
- Contribute to the consulting activity: provide explanation , interpretation of the French regulations and EU regulations.
- Contribute to define the registration strategy for new chemical entities and mature products (medicine and medical device )
- Manage regulatory projects and coordinate the activities of a project team
- Prepare or contribute to the writing and review of regulatory documents for new chemical entities and / or medicinal/biotechnology products, perform the quality control and validate the final deliverable before it is sent to the client
- Interact with regulatory agencies
- Manage, mentor and develop regulatory teams on the regulatory, business, sales and marketing aspects
- Monitor client relationship, budget and satisfaction by interacting with them on a regular basis
- Monitor the quality of deliverables by ensuring they comply with the specifications and the allocated budget
- Write commercial proposals and answers to RfP (Request for Proposal)
- Contribute to the expansion of the client portfolio by generating new opportunities
- Ensure the conformity with the internal quality instructions
- Present at conferences or webinars, write blogs and posts
- Completed Scientific University or engineer Master degree
- A minimum of 6 to 8 years of professional experience and technical/project management experience
- Knowledge of French and European regulations and regulatory requirements for medicinal products, medical devices
- Distinctly strong service orientation
- Content-related experience in several relevant area of Regulatory Affairs and more specifically registration strategies, MRP, DCP, CP
- French native speaker and English language fluency, written and spoken
- Ability to manage several projects with limited guidance
- Independent approach to work, flexibility and dedication
- Strong communication skills, social competency, integration capacity
- Strong sense of responsibility, organizational skills and intrinsic motivation
- An experience in a consulting environment would be a plus
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.