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.
Regulatory Specialist - Chemistry, Manufacturing & Control
- Assist in preparation of regulatory affairs documentation for submission to EU regulatory agencies.
- Assist in Life Cycle Management of approved products.
- Handling of M3 databases
- Compilation/handling of wToCs for renewals/variations
- Drafting of eAFs and country information letters for dispatch packages
- Communication with local affiliates regarding local requirements
- Change assessments according to EU variation guideline
- CMC background preferred, IT affinity, very detail oriented, excellent communication skills
- Maintain knowledge and understanding SOPs and current regulatory guidelines as applicable.
Experience: 2-3 Years
Qualification: Lifesciences Graduate/Post Graduate
Good presentation skills
Excellent communication skills, a quick readiness of mind, team player
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.
For further information please don’t hesitate to contact us:
Ms Vineeta Bisht
Manager Human Resources India