Orion Group Life Sciences have an exciting opportunity for a Regulatory Affairs Associate for our Multinational Pharmaceutical client based in the Middlesex area on an initial 12-month contract.
Job Purpose
The Senior Associate Regulatory Affairs (CMC) provides varying levels of product support to the Chemistry, Manufacturing and Controls (CMC) function, which is responsible for Module 3 of regulatory submissions across phases of product development from clinical to lifecycle. 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
.
Main Responsibilities of the role
Support may include:
- Organizing, managing and executing on regulatory CMC projects and submissions.
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.
Desired Experience and Background of the successful candidate
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
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
For more information on this role, call Ian Towler on +44 (0) 2039 944711 or email Ian.towler@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 933473
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.