FREE ACCESS
5,000–10,000 jobs/day
See all jobs on JobTailor
Search thousands of fresh jobs every day.
Discover
- Fresh listings
- Fast filters
- No subscription required
Create a free account and start exploring right away.
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
regulatory affairsEU regulatory requirementsICH guidelinesFormulations Analytical DevelopmentFormulations Developmentpharmaceutical product developmenteCTD submissionsregulatory skills development
Soft Skills
teamworkindependent worktask orientedlearning attitudecommunication
Tools & Technologies
Microsoft OfficeOrion internal regulatory system
Industry Keywords
pharmaceuticalregistration dossiersregulatory deficienciesvariationsannual reportsrenewals
About the role
Key responsibilities & impact- Responsible for preparation / checking / review of pharmaceutical / quality part (all forms) of registration dossiers and variations /amendments / annual reports / renewals as applicable documents according to EU regulatory requirements.
- To identify and classify the changes as per EU regulatory variation guidance.
- To prepare response to regulatory deficiencies letters according to EU regulatory requirements
- To collaborate with other departments/partners
- To maintain lists/documents/records
- Responsible for keeping Orion internal regulatory system up to date and accurate
- To achieve his/her responsibilities within the agreed timescales
- To actively participate in the development of regulatory skills within the regulatory team by continuous up-dating
- Other possible tasks appointed by Supervisors
Requirements
What you’ll need- 5 - 8 years' work experience in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines.
- Experience in Formulations Analytical Development, Formulations Development or Pharmaceutical product development activities and eCTD submissions will be an added advantage.
- Fluency in oral and written English
- Ability to work well independently as well as in a team environment
- Task oriented with learning attitude and Team work skills
- Familiarity with Microsoft Office
Benefits
Comp & perks- An excellent opportunity to work in an inspiring and important role in the area of Regulatory Affairs
- Great opportunity to become part of the wholly owned subsidiary of globally operating Orion Group
- Possibility to utilize your own strengths with the support of the professionals
- Flexible, high-spirit working environment where your skills are appreciated
- Hybrid Work Policy (In a week - 3 days work from office and flexibility to work remotely for two times).
- Good work-life balance
- Clear, transparent processes and responsible supervisors are our benefits to the personnel