We have vacancy in Regulatory Affairs team for an Assistant role. This individual will be based in Mumbai. The candidate has the possibility to utilize his/her own strengths with the support of the professionals.
Job Description And Responsibilities
- Responsible for the Life Cycle Management of assigned products according to guidelines and instructions.
- Ensure compliance of products according to the guidelines and instructions.
- Responsible for keeping Orion Internal Regulatory systems up to date and accurate.
- Keep the regulatory archive complete and ensure that all current licenses and labelling are up to date.
- Coordination with Internal and External stakeholders for effectively handling the change.
- Follow and comply with all the defined internal policies and procedures of working.
- Assist with electronic formatting of submissions of global regulatory filings,
in accordance with agency guidance.
- Miscellaneous administrative activities as assigned.
- Other possible tasks appointed by Supervisor.
Primary Skills (essential):
- Preferably 2-3 years of experience within the regulated industry .
- Experience on Product lifecycle management will be an added advantage.
- Knowledge of EU requirements and ICH guidelines will be an added advantage.
- Fluency in English (oral and written).
- Develops cross-functional co-operation.
- Ability to work on different software and systems.
- Ability to work well independently as well as in a team environment.
- Task oriented with learning attitude and Teamwork skills.
- Proficient use of technology including MS Office Software Package (Word, Excel, PowerPoint, and Outlook), Adobe Acrobat and Internet resources are expected.
- eCTD submissions experience will be an added advantage.