About your role We have vacancy for Global Regulatory Expert role in Regulatory Affairs team. We are looking for Specialist/Sr. Specialist. This individual will be based in Mumbai/ Hyderabad. The candidate has the possibility to utilize his/her own strengths with the support of the professionals. Your

key responsibilities

- Responsible for preparation / checking / review of pharmaceutical / quality part (all forms) of registration dossiers and variations /amendments / annual reports / renewals as applicable documents and submissions according to EU regulatory requirements.
- To identify and classify the changes as per EU regulatory variation guidance.
- To prepare response to regulatory deficiencies letters according to EU regulatory requirements
- To collaborate with other departments/partners
- To maintain lists/documents/records
- Responsible for keeping Orion internal regulatory system up to date and accurate
- To achieve his/her responsibilities within the agreed timescales
- To actively participate in the development of regulatory skills within the regulatory team by continuous up-dating 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 at large. Our culture of friendliness, respect, mutual appreciation and diversity creates a safe working environment where you can strive for excellence.

We offer
a wealth of career paths and development opportunities that support the development of cutting-edge solutions and improving the quality of life. Please visit our website to find further information about our values and Orion as an employer https://www.orion.fi/en/careers/orion-as-an-employer/ . Our expectations Essential competences, education and way of working
- 7
- 12 years' work experience in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines.
- Experience in Formulations Analytical Development, Formulations Development or Pharmaceutical product development activities and eCTD submissions will be an added advantage.
- Fluency in oral and written English
- Ability to work well independently as well as in a team environment
- Task oriented with learning attitude and Team work skills
- Familiarity with Microsoft Office Qualification: Bachelors / Master 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: 15.11.2026

📌 Sr. Specialist Regulatory Affairs (Mumbai)
🏢 Orion
📍 Mumbai