Senior Regulatory Affairs Officer - Compliance
- Company
- Thornshaw Recruitment
- Location
- Dublin (County), Leinster (IE)
- Salary
- Negotiable depending on experience
- Posted
- 25 Feb 2021
- Closes
- 27 Mar 2021
- Ref
- ZHJO-2101-461595
- Discipline
- Quality, GMP, Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
On behalf of our client, a leading global pharmaceutical company, we are currently recruiting for a Senior Regulatory Officer Submissions. This is a permanent, full-time role.
Main Objective of Role
- All general RA activities as per RA Officer Compliance job specification e.g.:
- Manage new applications, variations and maintenance of International MA’s
- Gap analysis and remediation of International CMC documentation
- Build and develop International regulatory strategy and regulatory intelligence
- Collaboration with stakeholders to support active MA’s and related activities
- In addition to items outlined below
- Lead by example in completing tasks and interacting with colleagues and stakeholders
- Team mentoring and training
- Continuous development awareness
Other activities as assigned by Team Leader / Manager / Head
Job Duties
SENIOR OFFICER EXPECTATIONS
- Lead project teams or working groups as directed by management
- Provide mentoring and support for new starters and less experienced team members
- Representing RA Compliance at relevant meetings / telecons / WebExs
- Lead by example to ensure tasks are completed in a timely and effective manner
- Lead by example by displaying ownership and taking accountability for assigned activities
- Proactive identification and reporting of potential issues to management
- Ongoing process and systems assessment to enable continuous development
- Develop / deliver training as appropriate
- Contribute to the development and implementation of RA policies, processes, SOPs and other
DOSSIER MANAGEMENT
- As per RA Officer Compliance job specification
- Peer review of dossier documents for accuracy, completeness and compliance
- Oversee dossier build timelines for any assigned team projects
- Timely escalation of issues causing delays with dossier development
REGISTRATION PROCESS
- Assist RO’s with managing risks and evolving timelines, and with remediation of issues
PERSONAL DEVELOPMENT
- Identify and communicate perceived key strengths to management in order to work more effectively and assist manager with smart project planning
Minimum Skills / Experience:
- Life sciences (BSc in Chemistry/ Biology, etc.) or pharmacy degree
- Minimum 3 years experience in a regulatory affairs environment
- Relevant experience in, and general knowledge of, the pharmaceutical industry
- Knowledge of EU and other regions current registration and dossier requirements
- Knowledge and ability to source International registration requirement information
- Excellent computer competency e.g. Word, Excel, Access, Powerpoint etc
- Experience with systems and tools specific for RA and pharmaceutical sector
For a full Job Spec and to apply for this role please call Zoe on +353 1 2784671 or e-mail zhamilton@thornshaw.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671
Apply for Senior Regulatory Affairs Officer - Compliance
Already uploaded your CV? Sign in to apply instantly