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 Affairs CMC Biologics
- Lead and support CMC biologics activities for international PharmaLex projects.
- Provide a broad range of regulatory affairs support for the UK regulatory function, with a particular focus on CMC for biologics.
- Proactively support local and international teams to deliver quality CMC work to clients
- Provide a wide range of flexible regulatory affairs services for different clients on a range of product types and therapeutic areas.
- Provide leadership and knowledge-based support for biologics CMC activities (e.g. compilation and review; gap analysis; CMC strategies; comparability exercises)
- Provide project management for regulatory activities
- Manage clients and other stakeholders
- Support business development; provide input into client proposals
- Provide critical technical review of documentation based on established experience
- Provide effective consulting support for CMC biologics
- Established experience in regulatory affairs activities including
- Module 3 IND/IMPD authoring and review
- MAA/BLA gap analysis
- Development of regulatory strategy
- Scientific advice procedures
- Submission management
- Experience with different territories, authorization procedures and health authorities
- Experience with development and life-cycle management products
- Experience in biologics e.g. regulatory affairs, manufacturing, quality systems, process, analytical
- Established experience with a wide range of biotech product types including: ATMPs, vaccines, recombinant proteins and biosimilars.
- Focused and able to deliver high-quality work.
- Strong work ethic and proven adaptability to meet client needs
- Ability to work in a team.
- Strong sense of responsibility.
- Excellent written and verbal communication skills, with a particular focus on client-facing interactions.
- Educated to at least a relevant science degree level, preferably with a higher degree in a pharmaceutical discipline.
- At least seven years of experience in the biotech industry.
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.