Officer-Regulatory Affairs

Job Description

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:  

Bachelor’s 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
  
  

About Us

Orion Pharma is a globally operating Nordic pharmaceutical company – a builder of well-being for over a hundred years.

We’re home to more than 4,000 Orionees around the world, and we’re proud to be known as a responsible employer and a great place to work. At Orion Pharma, people are truly valued and trusted, encouraged to grow, and supported by a culture where every voice is heard. We appreciate each other, strive for excellence, and build the future.

Together we develop, manufacture, and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines as well as consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion Pharma are used to treat cancer, neurological diseases, respiratory diseases, and more.

We offer careers with a clear purpose: empowering people to live their lives to the fullest.