We are searching for a well-known pharmaceutical group located in Madrid a CMC Senior RAO Specialist. Our client offers a headquartered position in its international RAO team located in Spain which is registering dossiers (own products and licensed ones) around the world. Direct hire and permanent contract is offered with interesting opportunities of careers development.
The CMC Regulatory Affairs Specialist is responsible for the development of regulatory affairs strategies specific to quality dossiers, and submission and negotiation of regulatory submissions from clinical trial to the post-market stage. The incumbent will ensure quality compliance of post-approval activities. In this role, the incumbent will focus on preparing and following up on Chemistry, Manufacturing, and Controls files, as well as work closely with multiple scientific, technical, quality, and commercial areas within the company. The incumbent will elaborate the eCTD dossier from zero M1 to M5 for generic products.
This position also works closely with the QA and also directly interacts with manufacturing sites as needed. Externally this position interacts with Health Authorities, industry organizations, consultants, vendors, and health care professionals.
Providing CMC oversight and regulatory interface with Health Authorities
Review (including conducting regulatory impact assessments), coordinate and prepare CMC documentation for Clinical trial Applications (CTA), CTD modules of submissions, registration and lifecycle management variations.
Obtaining and maintaining regulatory approvals
Transfer of registered data to registration summaries and updating of electronic regulatory information system
Management of regulatory affairs electronic storage of CMC data
Participate as required in project Launch Meetings, Review Meetings and Project Team meetings
SKILLS AND QUALIFICATIONS:
Bachelor of Science
3-4 years of experience in regulatory affairs in the pharmaceutical industry.
Significant experience with CMC modules I, II, III and international regulations and file transfers
Detail oriented person, with strong capability to multi-task
Understanding of pharmaceutical manufacturing a strong asset
Ability to work well both independently and in a team environment
• Solid decision making skills with strategic mindset. • Excellent communications skills (verbal, written, listening, conveying messages) • Solid computer skills • Experience in Quality Assurance/Quality Control • Experience with eCTD and non-CMC regulatory affairs is an asset
Candidates must send CV and application letter in English to firstname.lastname@example.org.
Prior CMC / Module 3 experience is MANDATORY.