Orion Pharma Hiring Officer – Regulatory Affairs (Assistant Role)
- Orion Pharma Hiring Officer – Regulatory Affairs | BSc, BPharm | Mumbai Hybrid
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities
- Eligibility & Qualifications
- Educational Background
- Experience & Skills Required
- Location & Employment Details
- Application Process
- Why Choose a Career in Regulatory Affairs?
- Frequently Asked Questions (FAQs)
- 1. Is prior regulatory experience mandatory?
- 2. Is knowledge of EU regulations required?
- 3. Does the role involve eCTD submissions?
- 4. Is this a remote role?
- 5. What career growth opportunities are available?
- Summary Table
Orion Pharma Hiring Officer – Regulatory Affairs | BSc, BPharm | Mumbai Hybrid
Orion Pharma is inviting applications for the position of Officer – Regulatory Affairs (Assistant Role) in its Regulatory Affairs team based in Mumbai, India. This is a full-time hybrid opportunity for candidates with 2–3 years of experience in the regulated pharmaceutical industry. The role focuses on product lifecycle management, regulatory compliance, eCTD submission support, and maintenance of internal regulatory systems.
If you are a science or pharmacy graduate looking to strengthen your career in global regulatory affairs, EU submissions, and ICH guideline-based documentation, this position offers exposure to structured regulatory processes within a globally operating pharmaceutical organization.
Company Overview
entity[“organization”,”Orion Pharma”,”nordic pharmaceutical company”] is a globally operating Nordic pharmaceutical company with over 100 years of history in developing, manufacturing, and marketing human and veterinary medicines. With more than 4,000 employees worldwide, Orion Pharma is recognized as a responsible employer committed to innovation, compliance, and patient well-being.
The company’s portfolio includes proprietary and generic medicines, consumer health products, and active pharmaceutical ingredients (APIs). Its core research and development therapy areas include oncology, pain management, neurology, and respiratory diseases. Orion-developed medicines are used worldwide to treat cancer, neurological disorders, and other critical health conditions.
As a wholly owned subsidiary of the Orion Group, the India team contributes to global regulatory submissions, lifecycle management, and compliance processes aligned with international standards.
Job Role & Responsibilities
The Officer – Regulatory Affairs will support lifecycle management activities and ensure regulatory compliance for assigned pharmaceutical products. The role requires close coordination with internal and external stakeholders to maintain up-to-date regulatory documentation and submission records.
Key Responsibilities
- Manage product lifecycle activities in accordance with regulatory guidelines and internal SOPs.
- Ensure ongoing compliance of assigned products with applicable regulations.
- Maintain and update Orion’s internal regulatory systems and documentation databases.
- Keep regulatory archives complete and ensure all licenses and labeling components remain current.
- Coordinate effectively with cross-functional teams and external stakeholders to manage product changes.
- Assist with electronic formatting of global regulatory submissions in line with agency guidance.
- Support eCTD documentation and submission activities.
- Perform administrative and documentation tasks as assigned by the supervisor.
- Follow defined internal compliance policies and quality processes.
The role requires strong attention to detail, organizational capability, and familiarity with regulatory submission workflows.
Eligibility & Qualifications
Educational Background
Bachelor’s degree in Science or related discipline from a reputed college or university.
Eligible qualifications include:
B.Pharm, M.Pharm, BSc Chemistry, MSc Chemistry, BSc Life Sciences, MSc Life Sciences, Pharmaceutical Sciences, Regulatory Affairs, Biotechnology, Microbiology, or related scientific fields.
Experience & Skills Required
- 2–3 years of experience in a regulated pharmaceutical industry environment.
- Experience in product lifecycle management preferred.
- Knowledge of EU regulatory requirements and ICH guidelines is an added advantage.
- Familiarity with eCTD submissions and electronic regulatory documentation.
- Strong written and verbal communication skills in English.
- Ability to work independently and collaboratively in a team setting.
- Proficiency in MS Office (Word, Excel, PowerPoint, Outlook), Adobe Acrobat, and internet research tools.
- Strong cross-functional coordination skills.
- Task-oriented mindset with strong learning attitude.
Candidates with hands-on experience in regulatory compliance tracking systems and submission document preparation will have a competitive edge.
Location & Employment Details
- Location: Mumbai, India (Hybrid Work Model)
- Employment Type: Full-Time
- Office Address: Smartworks Coworking Location, Times Square Building, Andheri East, Mumbai
- Application Deadline: 27.02.2026
Application Process
Interested candidates should email their CV/Resume to:
Applicants must include the following details in their email:
- Updated CV/Resume
- Current CTC
- Expected CTC
- Notice Period
Alternatively, candidates may apply through the official Orion Careers portal:
Early applications are recommended before the application deadline.
Why Choose a Career in Regulatory Affairs?
Regulatory affairs professionals play a critical role in ensuring that pharmaceutical products meet international safety, quality, and compliance standards. From dossier preparation to lifecycle maintenance, regulatory teams ensure uninterrupted product availability across global markets.
With increasing global harmonization of regulations and expansion of EU and ICH frameworks, experienced regulatory professionals are in high demand. This role provides exposure to international submission processes, regulatory intelligence, and compliance-driven pharmaceutical operations.
Professionals in this field often progress into Regulatory Affairs Manager, Global Submission Lead, CMC Regulatory Specialist, or Regulatory Strategy roles within multinational pharmaceutical companies.
Frequently Asked Questions (FAQs)
1. Is prior regulatory experience mandatory?
Yes, 2–3 years of experience in a regulated pharmaceutical environment is preferred.
2. Is knowledge of EU regulations required?
It is not mandatory but considered a strong advantage.
3. Does the role involve eCTD submissions?
Yes, assisting with electronic formatting and submission support is part of the responsibilities.
4. Is this a remote role?
No, this is a hybrid position based in Mumbai.
5. What career growth opportunities are available?
The role can lead to senior regulatory affairs positions and global submission strategy roles.
Summary Table
| Company | Orion Pharma |
| Vacancies | Officer – Regulatory Affairs |
| Required Education | B.Pharm, M.Pharm, BSc/MSc Chemistry, Life Sciences, Pharmaceutical Sciences, Biotechnology, Microbiology |
| Experience | 2–3 years in regulated pharmaceutical industry; lifecycle management preferred |
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