Contract and GRC Analyst
X-Lab
Senior Regulatory Affairs Associate, CMC – Plasma Products
Parexel
full-time
Posted on:
Location Type: Remote
Location: Remote • 🇬🇧 United Kingdom
Visit company websiteJob Level
Senior
Tech Stack
Vault
About the role
- Manage lifecycle maintenance activities, including renewals, variations, and responses to deficiency letters
- Coordinate submission and management work in Veeva Vault
- Collaborate with various stakeholders, attending regular calls and meetings
- May serve as Project Lead for small-scale projects or Work Stream Lead on larger projects
- Ensure project team delivers high-quality work meeting client expectations and timelines
- Manage project financials and identify new business opportunities
- Deliver consulting services within your area of expertise
- Maintain professional interactions with clients and internal teams
Requirements
- University degree in a life science discipline
- Initial years of regulatory experience in EU and other non-EU markets preferred
- Proficiency in Module 1 and 3 writing for plasma products
- Strong organizational and prioritization skills
- Excellent communication and teamwork abilities
- Ability to work independently and under guidance of Project Leads or Technical SMEs
- Commitment to continuous learning and self-development
- Fluent in English, written and spoken
Benefits
- Flexible work arrangements
- Professional development opportunities
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory experienceModule 1 writingModule 3 writingproject financial managementconsulting services
Soft skills
organizational skillsprioritization skillscommunication abilitiesteamwork abilitiesindependent workcommitment to continuous learning
