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.
Senior Manager, Regulatory Affairs CMCs
This role provides a broad range of regulatory affairs support for the UK regulatory function, with a particular focus on CMC for biologics.
Lead and support CMC biologics activities for international PharmaLex projects. .
- 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 biologics activities
Key Decisions made by the role
- Day to day technical decisions with regards to the criticality of technical content of documents/data under review.
- Day to day decisions regarding the level and type of consulting advice provided and whether additional
- Day to day project management decisions to ensure project is delivered as requested (time/quality)
- Concentrated and high-quality work.
- 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.
- Established experience in regulatory affairs activities including: Module 3IND/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.
- 25 Days holiday plus BH (increasing to 27 after qualifying service)
- 8% employer pension contribution
- The role can be based at any of our UK locations.
- An opportunity to work within an organisation with a positive work/life balance environment
- Continuous development opportunities through knowledge and experience as well as training
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 receiving your CV and a covering letter, explaining how you meet or exceed the specifications for this position, including your salary expectations on-line.
To apply, please use the "apply now" button below
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