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Technical Regulatory Affairs Manager, CMC **CONTRACT - PHARMACEUTICAL INDUSTRY**

Job Number:
J0822-0045
Job Type:
Contract
Job Category:
Science
Location:
Montreal, Quebec
Salary:
Open

Technical Regulatory Affairs Manager, CMC **CONTRACT - PHARMACEUTICAL INDUSTRY**

LOCATION: Montreal, QC
INDUSTRY: Pharmaceutical
JOB TYPE: Contract
ESTIMATED DURATION: Six (6) months from start date
START DATE: Immediate

***VERY IMPORTANT***

HYBRID WORK MODEL: Ideally 1-2 days a week on site at the Montreal office located in Old Montreal & at the Quebec City production site, but can be fully remote if needed.

WORK HOURS: 37.50 hours a week. Day shift, Monday to Friday

PLEASE SEND YOUR RESUME TO CAROLE.VIGER@GROOMASSOCIES.COM

We thank all candidates for showing interest in this role; however, only retained candidates will be contacted.

For more information on our recruitment services, please visit our website www.groomassocies.com

TECHNICAL REGULATORY AFFAIRS MANAGER - CMC

FUNCTION DESCRIPTION
The mission involves:
- Definition of the strategy for the submission of technical (quality) changes
- Preparation, authoring and coordination of CMC submissions related the life-cycle maintenance of Vaccines (CMC variations, commitments, market expansions, answers to questions from world-wide regulatory authorities).
- Maintenance of regulatory dossiers.
- interactions with regulatory and technical contributing disciplines Teams (QC, QA, Production, Supply) to ensure File content definition,
- Use of regulatory information management systems such as Documentum, Liquent, and Veeva Vault

KEY RESPONSIBILITIES:
• Under supervision of a CMC manager, liaise with contributing disciplines to define technical file content
• Ensure planning and proper organisation of activities (for technical/CMC and procedural aspects) in line with the overall project plan and RA milestones
• Compile/write high quality project/product specific regulatory documents to be submitted to Authorities (for technical/CMC and procedural sections) and ensure that those documents meet regulatory requirements.
• Ensure coordination of activities related to CMC submission file preparation, including change control assessment, source documents collection from key contributing discipline, initiation and management of CMC submission kick-off meeting, file authoring, review and approval
• Provide support to the supervisor via critical review of the technical section of regulatory documents
• Ensure liaison with and coordination between RA teams, RA management, Regulatory operations and any other stakeholders involved in the program
• Report significant issues to management

PREREQUISITES:

Education:
• Bachelor’s degree (Life Sciences background) or equivalent by experience.

Knowledge:
• Knowledge of regulatory procedures / systems / guidance
• Knowledge of Technical Regulatory Life Cycle Management
• Knowledge of biological products
• Very good level of spoken and written English. Knowledge of French is an asset
• Minimum 3-5 years pertinent experience
• Experience in CMC regulatory affairs / Technical Life Cycle Management, preferably with biologicals/vaccines, proven proven ability to manage typical regulatory activities, resolve problems and deliver results.
• Experience in CMC authoring of CMC technical variations and Module 3 components, , preferably with biologicals/vaccines,
• Experience in Project Management
• Experience in change control process
• Experience working with Biologics/vaccines preferred
• Experience with managing submissions in EU, US and major regulatory markets preferred

Skills:
• Fluent in English (will be required to interact daily with teams based around the world)
• Quality mindset - Ensure rigorous scientific content/quality/compliance of documents intended for regulatory submissions.
• Manages own time to meet agreed short-term targets. Ability to clearly identify prioritizes and manage multiple tasks
• Good communication skills
• Analytical skills, creative and critical mind
• Team player

Votre partenaire en recrutement – Your recruitment partner www.groomassocies.com