Lead compliance oversight for the Pan European Citco entities. Build stakeholder relationships and manage compliance risks across the organization.
About the role
- Officer in Regulatory Affairs in Mumbai, handling product lifecycle management in a pharmaceutical company. Ensuring compliance and keeping systems up to date while coordinating with stakeholders.
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.
Requirements
- 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.
Benefits
- 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.
- Good work-life balance.
- Clear, transparent processes and responsible supervisors are our benefits to the personnel.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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