pharmalex_job_career

We are growing, grow with us

Are you eager to work in a dynamic company where new challenges and opportunities are part of your every day work life? Then make PharmaLex your career choice! 

 PharmaLex is the leading service provider for the worldwide pharmaceutical industry in regulatory affairs, pharmacovigilance development consulting and quality management & compliance. We are specialized in effectively designing all aspects of drug and medicinal product registrations - ranging from early development and market entry to product maintenance activities. 
The success of our company resides in the expert knowledge and high motivation of our employees.

 
We are looking for a motivated and committed candidate who will enjoy working independently within our successful team in a dynamic and rewarding environment. So, if your career is much more than just a job for you but rather your passion, then come and join our successful team. In Bourne End we are looking for a 

Senior Specialist/Manager, Regulatory Affairs CMC (Biologics)

Your Job

  • Provide a wide range of flexible regulatory affairs services for different clients on a range of product types and therapeutic areas
  • Expert support/leadership 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
  • For a Manager, critical technical review of documentation based on established experience
  • Consulting support for CMC biologics activities
  • Day to day project management decisions to ensure project is delivered as requested (time/quality)
  • For a Manager, day to day technical decisions with regards to the criticality of technical content of documents/data under review


We offer you

Exciting and varied challenges in a friendly team, contact and interaction with nearly all branches of the company, as well as many opportunities for personal development and job training.

Your Profile

  • Between five and seven years of experience in the biotech industry
  • Preferably a higher degree in a pharmaceutical discipline
  • Established experience with a wide range of biotech product types including: recombinant proteins, biosimilars and for a Manager ATMPs and Vaccines
  • Manager only; Established experience in regulatory affairs activities including: Module 3IND/IMPD authoring and review, MAA/BLA gap analysis and regulatory strategy and scientific advice procedures
  • Structured, analytical, systematic thinker
  • Strong communication skills
  • Concentrated and high-quality work
  • Ability to work in a team
  • Strong sense of responsibility
  • Excellent written and verbal communication skills, with a focus on client-facing interactions