REG, Senior Specialist Publishing

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.

##Locations: Noida/Mumbai/Hyderabad

REG, Senior Specialist Publishing


Your Job

• Create, compile and validate eCTD and NeeS including MAAs, amendments, variations, renewals, etc.
• Life-Cycle Management of approved products (electronic only).
• Editing of documents according to ICH guidelines (Create bookmarks and links, etc.).
• Preparation of presentations, SOPs and Wls for Internal training.
• Training for various software tools

Your Profile

• Graduate/Post-graduate/Doctorate degree in life sciences/Pharmacy/Medical sciences or equivalent degrees
• Minimum 2 years of professional experience within the pharmaceutical industry in Regulatory affairs
• Basic experience in technical and high-quality work
• Basic Knowledge of regulatory affairs
• Ability to work in a team
• Very good command over English
• Proficiency with Microsoft Office
• Ability to manage and prioritise multiple tasks, especially during stringent timelines.
• Sense of responsibility with good organizational and communication skills.

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