Regulatory Affairs CMC Associate
CPL have partnered with a well established Biotechnological company who are at the forefront of this industry. Company is looking to add a individual ideally with some experience working in this field, who can hit the ground running.
Overview of role
CMC submissions globally, compiling submissions for all countries for clinical trials and marketing applications. Lots of work with strict timelines, working well stakeholders and timeline pressures
Candidate MUST haves:
• Strong written and communication skills
• Degree in life sciences, biochemistry, or chemistry
• Candidates need to be able to demonstrate a proactive nature
Manager is open to graduates with limited experience, the IDEAL candidate would have 1-year regulatory experience in a similar role.
Details
Location: Uxbridge
Working hours: Full time hours 5 days a week
Working type: Hybrid (In the office 2 times a month)
Wage: £15.00 per hour
Contract Length: 12 Months
Job Description
Brief Description:
Tasks may include creating and/or maintaining submission timelines and tables of contents, formatting of documents per style guide, scheduling meetings, drafting meeting agendas and minutes, managing document reviews and other tasks as requested. Ideal candidate has:
• proficient skills in Microsoft Office suite, especially Word, Excel, PowerPoint and Project;
• strong organizational skills with attention to detail;
• excellent time management skills and ability prioritize workload;
• project management skills;
• adept interpersonal and communication skills (both verbal and written);
• ability to work both independently and as a member of a team.
Preferred Qualifications:
• Degree in life sciences, biochemistry, or chemistry
• Experience in biopharmaceutical or pharmaceutical industry
• Familiarity with eCTD structure
• Motivated with initiative to learn quickly
• Experience in CMC, including preparation of submissions to Agencies
If this role matches your experience or you have an interest in finding out more information please feel free to contact me via email