Remote: Hybrid

About your roleWe 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 responsibilitiesResponsible 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 requirementsTo collaborate with other departments/partnersTo maintain lists/documents/recordsResponsible for keeping Orion internal regulatory system up to date and accurateTo achieve his/her responsibilities within the agreed timescalesTo actively participate in the development of regulatory skills within the regulatory team by continuous up-datingOther possible tasks appointed by SupervisorsWhat we offerAn 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 excellence. We offer a wealth of career paths and development opportunities that support the development of innovative 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 expectationsEssential competences, education and way of working7 - 12 years' workexperience 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 EnglishAbility to work well independently as well as in a team environmentTask oriented with learning attitude and Team work skillsFamiliarity with Microsoft OfficeQualification:Bachelors / Master degree in Pharmacy or Chemistry from a reputed College / UniversityHow to apply and additional informationEmail 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 career site
📍 Mumbai