Assistant Manager – Regulatory Affairs
Location: Mumbai / Hyderabad, India (Hybrid)
Job Type: Full-Time, Permanent
About Orion Pharma
Orion Pharma is a globally operating Nordic pharmaceutical company with over 100 years of expertise in developing and manufacturing human and veterinary pharmaceuticals and active pharmaceutical ingredients. Our extensive portfolio includes proprietary and generic medicines, as well as consumer health products, with a strong focus on oncology, pain management, neurological, and respiratory therapies.
At Orion, employees are valued, trusted, and encouraged to grow in a culture of excellence, collaboration, and innovation. We offer flexible hybrid work models and a workplace where every voice is heard.
Role Overview
The Assistant Manager – Regulatory Affairs will act as a Global Regulatory Expert responsible for the preparation, review, and management of pharmaceutical registration dossiers, variations, amendments, renewals, and annual reports in compliance with EU regulatory requirements and ICH guidelines.
This role will require cross-functional collaboration, meticulous documentation, and active contribution to regulatory strategy and lifecycle management.
Key Responsibilities
Prepare, check, and review pharmaceutical and quality sections of registration dossiers and submissions.
Identify and classify changes according to EU regulatory variation guidance.
Prepare responses to regulatory deficiency letters and ensure compliance with EU requirements.
Maintain and update internal regulatory systems, ensuring accurate records.
Collaborate with other departments and external partners to facilitate regulatory compliance.
Manage lifecycle documentation, including variations, amendments, renewals, and annual reports.
Participate in continuous learning initiatives to strengthen regulatory skills within the team.
Perform other regulatory tasks as assigned by supervisors to support organizational goals.
Qualifications & Experience
Essential:
Bachelor’s or Master’s degree in Pharmacy or Chemistry from a reputed institution.
Minimum 8 years of experience in international regulatory affairs within the pharmaceutical industry.
Confirmed knowledge of EU regulatory requirements and ICH guidelines, with specific experience in product lifecycle management.
Strong fluency in oral and written English.
Ability to work independently and collaboratively in a hybrid work environment.
Familiarity with Microsoft Office applications.
Preferred / Advantageous:
Experience in Formulations Analytical Development, Formulations Development, or Pharmaceutical product development.
Hands-on experience with eCTD submissions.
Why Join Orion Pharma
Be part of a globally respected pharmaceutical organization with a century-long legacy.
Contribute to cutting-edge drug development that impacts patients worldwide.
Enjoy a flexible hybrid working model (3 days office, 2 days remote).
Thrive in a culture of learning, collaboration, and career development.
Access opportunities for professional growth and innovative project contributions.
Application Process:
Send your CV/resume to recruitmentindia@orion.fi with the following details:
Current CTC, Expected CTC & Notice Period
Supporting documents (CV/Resume)
Application Deadline: 3rd December 2025
Orion Pharma is an equal opportunity employer, fostering a diverse, inclusive, and respectful workplace.
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