Regulatory Affairs Senior Executive Job – at Orion, Apply Now!
Are you a regulatory affairs professional looking to make a global impact? Orion, a Finnish pharmaceutical leader, is hiring a Senior Executive – Regulatory Affairs in Mumbai. This hybrid role allows you to contribute to CMC regulatory processes, collaborate with international teams, and grow within a transparent, innovative work culture. If you have expertise in EU regulations and pharmaceutical product development, this is your chance to shine.
- Job Position: Senior Executive – Regulatory Affairs
- Location: Mumbai, India (Hybrid)
- Job ID: 417
About Us
Orion is a globally operating Finnish pharmaceutical company – a builder of well-being for over a hundred years. Orion provides meaningful work for more than 3,600 Orionees in Finland and abroad. Orion is known as a responsible and reliable employer where we value each other, strive for the best, and build for tomorrow.
About The Role
We have a vacancy for a CMC expert role in the Regulatory Affairs team. We are looking for Sr. Executive. This individual will be based in Mumbai. The candidate has the possibility to utilize his/her own strengths with the support of the professionals.
Your key responsibilities
- Responsible for the preparation/checking / review of pharmaceutical/quality part (all forms) of registration dossiers and variations /amendments / annual reports/renewals as applicable documents in Vness, CTD, and eCTD format according to EU regulatory requirements (Candidate will be mainly responsible for CMC / Module 3 work)
- To prepare responses to the quality part of regulatory deficiency letters according to EU regulatory requirements
- To collaborate with other departments/CMO-partners
- To maintain lists/documents/records
- Responsible for keeping Orion and V.M.D. internal regulatory system current and accurate, especially regarding CMC documents
- To achieve his/her responsibilities within the agreed timescales
- To actively participate in the development of regulatory skills within the regulatory team. Keep up to date with new CMC-related guidelines
- Other possible tasks appointed by Supervisors
What we offer
An excellent opportunity to work in an inspiring and important role in the area of Regulatory Affairs
- 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
- Hybrid Work Policy (In a week – 3 days work from office and flexibility to work remotely for two times)
- Good work-life balance
- Clear, transparent processes and responsible supervisors are our benefits to the personnel
- At Orion, your work creates true impact and well-being for our customers, patients and society
Our expectations
3 – 6 years’ work experience in international regulatory affairs from the Pharma industry and confirmed knowledge of EU requirements and ICH guidelines
- Experience in Formulations Analytical Development, Formulations Development or Pharmaceutical product development activities
- Fluency in oral and written English
- Ability to work well independently as well as in a team environment
- Task oriented with learning attitude and teamwork skills
- Familiarity with Microsoft Office
- Qualification: Bachelor’s / Master’s degree in Pharmacy or Chemistry from a reputed College / University
How to apply and additional information
Email your CV on [email protected] & please share below details,
- Required documents: CV/Resume
- Current CTC, Expected CTC & Notice Period
- Application deadline: 15.05.2025
Keywords: Senior Executive Regulatory Affairs Mumbai, Regulatory Affairs, CMC Regulatory Affairs job, Orion pharma careers, Pharmaceutical jobs India, CTD eCTD regulatory jobs, EU regulatory affairs
