Description
About your role
We have vacancy for Global Regulatory Expert role in Regulatory Affairs team. We are looking for Executive/Sr. Executive. 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 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 setting 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 ex

📌 Executive/ Sr. Executive Regulatory Affairs (Mumbai)
🏢 Orion Pharma
📍 Mumbai