Regulatory Affairs Sr. Executive (Hybrid) Hiring at Orion Pharma
- Orion Pharma Hiring Executive / Sr. Executive – Global Regulatory Affairs (EU Submissions) | Mumbai / Hyderabad | Hybrid
- Company Overview
- Job Role & Responsibilities
- Key Responsibilities
- Eligibility / Qualifications
- Educational Qualification
- Experience
- Preferred Experience
- Required Skills
- Location & Work Model
- Why This Role Is Strategic in Regulatory Affairs
- What Orion Offers
- Application Process
- Frequently Asked Questions (FAQs)
- 1. What experience is required for this role?
- 2. Is EU variation handling experience mandatory?
- 3. Is this a remote job?
- 4. Is eCTD experience required?
- 5. What are the long-term career prospects?
- Recruitment Summary
Orion Pharma Hiring Executive / Sr. Executive – Global Regulatory Affairs (EU Submissions) | Mumbai / Hyderabad | Hybrid
Orion Pharma is hiring for the position of Executive / Senior Executive – Regulatory Affairs under its Global Regulatory team. This full-time opportunity is based in Mumbai or Hyderabad with a hybrid work model (3 days office, 2 days remote). The role is ideal for regulatory professionals with 5–8 years of experience in international regulatory affairs, particularly EU submissions and lifecycle management activities.
This opening is suited for candidates with a strong background in pharmaceutical dossier preparation, variation management, and ICH-compliant regulatory documentation. If you hold a Bachelor’s or Master’s degree in Pharmacy or Chemistry and have hands-on exposure to EU regulatory procedures, this role offers strong global exposure within a reputed multinational pharmaceutical organization.
Company Overview
Orion Pharma is a globally operating Nordic pharmaceutical company with over a century of experience in building health and well-being. With more than 4,000 professionals worldwide, Orion develops, manufactures, and markets human and veterinary pharmaceuticals as well as active pharmaceutical ingredients.
The company’s portfolio includes proprietary and generic medicines along with consumer health products. Orion’s core research areas include oncology and pain management, along with therapies for neurological and respiratory diseases.
As a wholly owned subsidiary of the globally recognized Orion Group, the India entity plays a key role in supporting international regulatory operations and pharmaceutical product lifecycle management.
Job Role & Responsibilities
The Executive / Sr. Executive – Regulatory Affairs will focus on EU regulatory submissions and lifecycle maintenance activities for pharmaceutical products.
Key Responsibilities
- Prepare, review, and check pharmaceutical and quality (CMC) sections of registration dossiers in compliance with EU regulatory requirements.
- Handle variations, amendments, annual reports, renewals, and post-approval lifecycle submissions.
- Identify and classify changes according to EU variation guidelines.
- Draft and submit responses to regulatory deficiency letters.
- Collaborate with cross-functional departments and external partners.
- Maintain regulatory records, tracking lists, and documentation systems.
- Ensure internal regulatory systems remain accurate and up to date.
- Contribute to skill development within the regulatory team through knowledge sharing.
- Execute assigned regulatory tasks within agreed timelines.
Candidates will work on EU-focused submissions while adhering to ICH guidelines and global pharmaceutical legislation.
Eligibility / Qualifications
Educational Qualification
Bachelor’s or Master’s degree in Pharmacy or Chemistry from a reputed university.
Relevant Courses: B.Pharm, M.Pharm, Pharm.D, BSc Chemistry, MSc Chemistry, Pharmaceutical Chemistry, Industrial Pharmacy, Regulatory Affairs, Formulation Development, Analytical Chemistry.
Experience
- 5–8 years of work experience in international regulatory affairs within the pharmaceutical industry.
- Confirmed knowledge of EU regulatory requirements and ICH guidelines.
- Experience in handling pharmaceutical quality (CMC) documentation.
Preferred Experience
- Exposure to Formulation Development or Analytical Development activities.
- Experience with eCTD submissions.
- Knowledge of EU variation procedures and lifecycle management.
Required Skills
- Strong understanding of EU regulatory frameworks and pharmaceutical legislation.
- Ability to work independently and collaboratively.
- Task-oriented mindset with strong learning attitude.
- Excellent written and spoken English communication skills.
- Proficiency in Microsoft Office tools.
Location & Work Model
Locations:
- Mumbai – Andheri East (Smartworks Coworking – Times Square Building)
- Hyderabad – Smartworks Coworking Spaces
Work Model: Hybrid (3 days office, 2 days remote)
Job Schedule: Full-Time
Application Deadline: 15.03.2026
Salary details are not disclosed publicly. Compensation is aligned with industry benchmarks for mid-to-senior regulatory affairs professionals handling EU submissions.
Why This Role Is Strategic in Regulatory Affairs
EU regulatory compliance requires precise documentation, structured variation handling, and strong understanding of ICH standards. Errors or delays in regulatory submissions can directly impact product approvals and market access.
The Executive / Sr. Executive in Regulatory Affairs plays a central role in ensuring pharmaceutical products remain compliant with EU requirements throughout their lifecycle. By managing dossier updates, responding to health authority queries, and overseeing CMC documentation, this position strengthens global product continuity and regulatory reliability.
What Orion Offers
- Opportunity to work in a globally operating pharmaceutical group.
- Hybrid work flexibility and work-life balance.
- Exposure to international regulatory submissions.
- Supportive and respectful work culture.
- Clear career growth pathways in global regulatory affairs.
Orion fosters a culture of mutual respect, collaboration, and continuous professional development.
Application Process
Interested candidates should email their CV to:
Please include the following details:
- Updated CV/Resume
- Current CTC
- Expected CTC
- Notice Period
Alternatively, candidates may apply via the official career portal:
https://fa-esaq-saasfaprod1.fa.ocs.oraclecloud.com/hcmUI/CandidateExperience/en/sites/OrionCareers/job/1194?utm_medium=jobshare
Ensure your resume highlights EU regulatory submission experience, variation management, and CMC documentation handling.
Frequently Asked Questions (FAQs)
1. What experience is required for this role?
5–8 years of international regulatory affairs experience with confirmed EU regulatory knowledge.
2. Is EU variation handling experience mandatory?
Yes. Strong understanding of EU variation guidelines and lifecycle management is essential.
3. Is this a remote job?
No. It follows a hybrid model with three days in office per week.
4. Is eCTD experience required?
It is preferred and will be considered an added advantage.
5. What are the long-term career prospects?
Candidates can progress to Regulatory Manager, Global Regulatory Lead, or EU Regulatory Strategy roles.
Recruitment Summary
| Company | Orion Pharma |
|---|---|
| Vacancies | Executive / Sr. Executive – Regulatory Affairs |
| Required Education | Bachelor’s / Master’s in Pharmacy or Chemistry |
| Experience | 5–8 Years in International Regulatory Affairs (EU Focus) |
To apply for this job please visit fa-esaq-saasfaprod1.fa.ocs.oraclecloud.com.
