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Associate Regulatory Affairs (Senior)

  • Job reference: 925653
  • Location: Dún Laoghaire, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences
  • Date posted: 24/05/2019

Orion Group is recruiting for Regulatory Affairs Associate on behalf of our Biotechnology Client based on Dun Laoghaire - 12-month contract initially

Support the coordination, development and/ or execution of CMC regulatory registration activities in accordance with 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 a 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 another 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 the ability to work within a 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.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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