Senior Executive - Regulatory Affairs

Job Description

Job Description About your role We have vacancy for CMC expert role in 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 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 deficiencies 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 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 expectations 3 - 6 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 recruitmentindia@orion.fi & please share below details, Required documents, CV/Resume Current CTC, Expected CTC & Notice Period. Application deadline - 15.05.2025 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. We develop, manufacture and market human and veterinary pharmaceuticals and active pharmaceutical ingredients. Orion has an extensive portfolio of proprietary and generic medicines and consumer health products. The core therapy areas of our pharmaceutical R&D are oncology and pain. Proprietary products developed by Orion are used to treat cancer, neurological diseases and respiratory diseases, among others. Show more Show less