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 Regulatory Affairs Specialist, CMC
- Write or contribute to the writing and review of regulatory documents for CMC projects in accordance with the state of the regulations in force and in compliance with the commitments made to clients:
- Establish the list of documents necessary for the constitution of the dossiers
- Document analysis and evaluation
- Constitution of dossiers for CMC projects (variation application, MI answer, baselines) or other linked regulatory projects (renewals, MAA, ...)
- Submission (CP, MRP/DCP, National procedure)
- Participate in classification of variations according to regulation,
- Participate in audits or diagnosis of dossiers according to guidelines.
- Manage regulatory projects and coordinate the activities with affiliates, or external partners, if needed
- Participate in working meetings with clients
- Interact with the clients and ensure deliverables complying with the specifications, the allocated budget and within timelines.
- Maintain his level of knowledge in line with changes in regulations, national and European registration requirements
- Ensure the conformity with the internal quality instructions
- Contribute to marketing activities by writing the content of presentations for conferences, webinars, blogs and posts
- Successful completion of Master’s degree in natural sciences (medicine, pharmacy, biochemistry…),
- Minimum 2-3 years of professional experienceand project management experience
- Knowledge of French and European regulatory requirements for medicinal products
- Distinctly strong service orientation
- Content-related experience in relevant areas of Regulatory Affairs
- Ability to manage one or several activities within timelines
- 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 as mother tongue, and English language fluency, written and spoken
- Occasional travels can be expected
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.