Orion Pharma Regulatory Affairs Job – Chem & Pharma Apply Now!
Orion Pharma, a globally operating Finnish pharmaceutical company, is hiring a Senior Executive – Regulatory Affairs for its Mumbai office (Hybrid mode). If you have 3–6 years of experience in EU regulatory affairs (CMC), strong technical knowledge in Module 3, and a desire to contribute to global healthcare, this is your opportunity to join a well-respected pharma company with over a century of impact!
About the company:
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.
Job Description:
- Job Title: Senior Executive – Regulatory Affairs
- Location: Mumbai, India (Hybrid)
We have a vacancy for a CMC expert role in the Regulatory Affairs team. We are looking for a 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.
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 the 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 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 a learning attitude and Teamwork 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 – 15.05.2025
Keywords: Regulatory Affairs, CMC expert, EU regulations, pharmaceutical industry, Orion Pharma Job. Orion Pharma Regulatory Affairs Job – Chem & Pharma Apply Now!
