Officer-Regulatory Affairs

About your role:

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.

This job offers:

• 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.

Qualification:

Bachelors degree in science from a reputed College / University

How to apply and additional information

Email your CV on& please share below details

• Required documents CV/Resume
• Current CTC Expected CTC & Notice Period.
• Application deadline: 27.02.2026