Executive, Regulatory Affairs
Orion
full-time
Posted on:
Location Type: Hybrid
Location: Mumbai • India
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Job Level
About the role
- 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
- 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
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
regulatory affairsEU regulatory requirementsICH guidelinesFormulations Analytical DevelopmentFormulations Developmentpharmaceutical product developmenteCTD submissionsregulatory skills development
Soft Skills
teamworkindependent worktask orientedlearning attitudecommunication