Orion

Regulatory Affairs Officer

Orion

full-time

Posted on:

Location Type: Hybrid

Location: Mumbai • India

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About the role

  • 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.
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
Product lifecycle managementeCTD submissionsregulatory complianceelectronic formattingglobal regulatory filingsknowledge of EU requirementsICH guidelines
Soft Skills
cross-functional cooperationindependent workteamworktask-orientedlearning attitude