Olive Pharmascience Ltd. Hiring Regulatory Affairs Professionals | Multiple Openings
Apply now at Olive Pharmascience Ltd. for Regulatory Affairs roles. Openings for Managers, Executives, and Specialists. Location: India. 4-10 years exp.
Olive Pharmascience Ltd., a leader in the pharmaceutical industry, is expanding its Regulatory Affairs Department and is inviting experienced professionals to join its growing team. With multiple openings across managerial, executive, and specialist roles, this is an excellent opportunity for candidates with expertise in dossier development, submissions, CMC documentation, and regulatory strategy.
Company Overview
Olive Pharmascience Ltd. is committed to delivering innovative, high-quality medicines to global markets. With a strong focus on compliance, regulatory excellence, and industry best practices, the company plays a pivotal role in shaping healthcare solutions. Joining Olive means becoming part of a progressive organization that values expertise, growth, and impact.
Job Role & Responsibilities
1. Manager – Dossier Development
- Prepare and review CTD/eCTD Modules 1–5.
- Manage deficiency responses and coordinate cross-functional inputs.
- Ensure technical consistency, compliance, and audit readiness.
2. Executive – EU/UK Submissions
- Compile and format documents as per EMA/MHRA requirements.
- Support electronic submissions and compliance tracking.
- Monitor timelines for regulatory filings.
3. Analytical Bridging Specialist
- Prepare bridging write-ups and support P.2 development.
- Provide strategic input on softgel comparability.
- Collaborate with RA and Analytical teams to ensure compliance.
4. Regulatory Coordinator
- Align QA/Manufacturing documentation with regulatory modules (3.2.S & 3.2.P).
- Support change control and consistency across dossiers.
- Assist in maintaining compliance with global regulatory standards.
Eligibility / Qualifications
- Manager – Dossier Development: M.Pharm with 8–10 years of experience in generics; softgel knowledge preferred.
- Executive – EU/UK Submissions: B.Pharm/M.Sc. with RA training and 4–6 years in regulated filings.
- Analytical Bridging Specialist: M.Pharm/Pharmaceutical Sciences with 5–8 years in RA/Analytical functions.
- Regulatory Coordinator: B.Pharm/M.Sc. with 4–6 years in CMC documentation.
Relevant courses: B.Pharm, M.Pharm, M.Sc. (Pharmaceutical Sciences, Regulatory Affairs, Chemistry, Biotechnology).
Location & Salary
- Location: India (specific plant/site details to be shared during the process).
- Salary: As per industry standards, competitive packages offered for the right candidates.
Application Process
Interested candidates can apply by sharing their CV with the HR team. Drop your application or connect via direct message to learn more.
Send your resume to: [Insert HR Email Here]
Or DM “Hi” to the HR team to initiate the application process.
Why Join Olive Pharmascience Ltd.?
- Be part of a leading name in global pharmaceuticals.
- Opportunity to work on international regulatory filings.
- Exposure to diverse projects across EU/UK, US, and emerging markets.
- Growth-focused organization with strong industry reputation.
FAQs
Q1: What experience is required for the Manager – Dossier Development role?
A: 8–10 years of experience in dossier preparation and regulatory submissions, preferably in generics.
Q2: Are freshers eligible for these positions?
A: No, these positions require prior regulatory experience (minimum 4 years).
Q3: What therapeutic areas does Olive Pharmascience Ltd. focus on?
A: Olive works across multiple therapeutic segments with a strong portfolio in generics and softgel formulations.
Q4: How can I apply?
A: Share your CV via email to the HR address provided or connect with the recruitment team directly.
Q5: Does Olive offer growth opportunities?
A: Yes, Olive is known for providing career advancement opportunities, global exposure, and professional development.
Summary Table
| Company | Olive Pharmascience Ltd. |
|---|---|
| Vacancies | Manager – Dossier Development (1), Executive – EU/UK Submissions (1), Analytical Bridging Specialist (1), Regulatory Coordinator (1) |
| Required Education | B.Pharm, M.Pharm, M.Sc. (Pharmaceutical Sciences, Regulatory Affairs, Chemistry, Biotechnology) |
| Experience | 4–10 years depending on the role |
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