Senior Manager, Regulatory Affairs

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: Mumbai/Noida

Senior Manager (Level 1)


Your Job

• Collaboration in designing the strategy for the coordinated service(s) with the VDC.
• Provides a wide range of flexible regulatory affairs services for different clients on a range of product types and therapeutic areas.
• Provides Manager expert leadership and support for CMC activities including CMC project management, review and writing of CMC gap analysis and CMC strategies.
• QC review of documentation, compendial cross checking and report formatting.
• Critical technical review of documentation based on established experience.
•  Consulting support for CMC activities
• Acts as line manager of assigned staff.
•  Manages project coordination and resource allocation.

Your Profile

• Autonomous, concentrated and high-quality work
• Ability to work in a team
•  Sense of responsibility
•  Very good command of English
• Graduate/Post-graduate/Doctorate degree in life sciences/Pharmacy/Medical sciences or equivalent degrees.
•  5-8 years of relevant experience in Regulatory affairs/Biotech industry.
•  Well organized, attention to detail, sense of accuracy and right first-time approach.
•  Delivery at consistently high standard, whilst striving to exceed expectations.
• Excellent communication skills in English, written and verbal, with a particular focus on client-facing interactions.
•  Established experience in regulatory affairs activities including Module 3 IND/IMPD authoring and review, MAA/BLA gap analysis and regulatory strategy and scientific advice procedures.
•  Established experience with a wide range of biotech product types including: ATMPs, Vaccines, recombinant proteins and biosimilars.