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Contact Info
Kevin Silke
Life Science

01 507 9255
[email protected]
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Regulatory Affairs Specialist
Republic of Ireland
Process Engineer
GMP Inspector
Quality Engineer
Risk Manager
VP of R&D
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Senior Associate Regulatory Affairs

Reference:KGASVR-177123 Location: Dublin
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed

We’re currently recruiting for an exciting opportunity with an award winning pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.This position will involve Support the coordination, development and/ or execution of CMC regulatory registration activities in accordance with the company’s commercialization strategies and global regulatory plans.

Job Summary
The Associate Regulatory Affairs is responsible for the registration document(s) procurement, preparation and coordination. The Associate Regulatory Affairs will serve as liaison with other functional teams at the site in support of registration activities and generation and management of required documentation.
Works in collaboration with the Site RA CMC Team and other Global/Regional Teams as needed.

Key Activities
- Registration document(s) procurement, preparation, coordination submission and archival
- Coordinates legalization and delivery of registration documents following the instructions provided in the request.
- Maintains tracking and organization of documentation, including uploading in CSD tool or other document repository.
- Supports the Site Regulatory CMC Team in the compilation and preparation of marketing application and post-approval submissions as needed.
- Maintaining and optimizing relevant databases, tracking systems and document management processes to support the licenses.
Knowledge and Skills - Excellent written and verbal skills
- Knowledge of Good Manufacturing Practices (GMP) and good documentation practices
- Strong written and oral communication skills
- The applicant should have basic knowledge regarding CMC sections of a Marketing Application (BLA, NDA, IND, NDS)
- Proficient use of MS Office tools, SharePoint and strong computer aptitude.
- Must have ability to work within team environment, but maintain a level of autonomy for managing daily tasks and activities
- Solid working knowledge on document management systems such as Documentum.

Education & Experience
(Basic) Bachelor’s degree
-- OR --
Associate’s degree & 4 years of directly related experience
-- OR --
High school diploma / GED & 6 years of directly related experience

Education & Experience (Preferred)
- Bachelor’s degree or higher in Regulatory, Life Sciences, Biotechnology or related discipline.
- A minimum of 4 years of related pharmaceutical industry experience.

If you would like further Information you can contact the recruiter directly:

Kevin Silke | Tel: +353 (0) 1 507 9255