Olive PharmaScience Hiring Regulatory Affairs & Dossier Submission
- Company Overview
- Job Role & Responsibilities
- Eligibility / Qualifications
- Location & Salary
- Application Process
- Why Join Olive PharmaScience Ltd.?
- High CPC Keywords Used Naturally
- FAQs
- Summary Table
Regulatory Affairs & Dossier Submission Openings | Olive PharmaScience Mumbai
Olive PharmaScience hiring in Mumbai for Regulatory Affairs & Dossier Submission roles. Apply now! 5–10 years of experience required.
Olive PharmaScience Ltd., a leading pharmaceutical company based in Mumbai, is inviting talented professionals to join its growing team. The company is hiring experienced candidates for Regulatory Affairs (Regulated/ROW Markets) and Dossier Submission (Managerial Level) positions. This opportunity is ideal for professionals seeking growth in global regulatory operations and pharmaceutical documentation.
Company Overview
Olive PharmaScience Ltd. is a fast-emerging pharmaceutical organization focused on developing and supplying high-quality generics and specialty formulations. The company operates with a strong R&D foundation and compliance-driven manufacturing practices catering to regulated markets (USFDA, EMA, MHRA) as well as ROW regions. With a commitment to innovation, quality, and patient safety, Olive PharmaScience continues to strengthen its presence in global healthcare markets.
The company fosters a culture of excellence, empowering employees to take ownership and contribute to meaningful pharmaceutical advancements.
Job Role & Responsibilities
Olive PharmaScience is seeking skilled professionals to strengthen its Regulatory Affairs and Dossier Management teams.
1. Senior Executive – Regulatory Affairs (Regulated/ROW Markets)
Experience: 5–7 Years
Qualification: B.Pharm / M.Pharm / M.Sc (Pharmaceutical Sciences, Chemistry, or Life Sciences)
Key Responsibilities:
- Prepare, review, and compile regulatory dossiers for submission in regulated and ROW markets.
- Handle product registration, renewals, and post-approval variations.
- Coordinate with R&D, QA, and Production teams for technical document collection.
- Maintain compliance with international regulatory guidelines (USFDA, EMA, MHRA, TGA).
- Support lifecycle management and change control documentation.
2. Manager – Dossier Submission
Experience: 8–10 Years
Qualification: M.Pharm / M.Sc (Pharmaceutics, Regulatory Science, or related field)
Key Responsibilities:
- Oversee preparation and electronic submission of regulatory dossiers for multiple markets.
- Manage end-to-end lifecycle of product registration and approval processes.
- Review CTD, eCTD, and ACTD formats to ensure technical accuracy.
- Liaise with regulatory agencies and respond to deficiency letters.
- Lead a team of executives handling global submissions and compliance activities.
Eligibility / Qualifications
Educational Background:
B.Pharm, M.Pharm, or M.Sc in Pharmaceutical Sciences, Chemistry, Biotechnology, or Life Sciences.
Experience Required:
- Senior Executive: 5–7 years of regulatory experience (ROW & regulated markets).
- Manager: 8–10 years in dossier preparation, submission, and lifecycle management.
Preferred Skills:
- Hands-on experience in CTD/eCTD dossier compilation.
- Understanding of global regulatory frameworks (USFDA, EMA, TGA, WHO, MHRA).
- Excellent communication and coordination skills.
- Ability to manage multiple submissions and timelines simultaneously.
Location & Salary
Work Location: Olive PharmaScience Ltd., Mumbai, Maharashtra
Salary: Competitive; commensurate with experience and qualifications.
Application Process
Interested candidates can share their resumes directly with the HR team by sending a direct message (DM) or applying via official communication channels.
How to Apply:
- Prepare an updated resume highlighting relevant regulatory or dossier experience.
- Mention the position title in the subject line.
- Send your profile directly through DM or via HR contact.
Company Location: Olive PharmaScience Ltd., Mumbai, India
Why Join Olive PharmaScience Ltd.?
- Work with an innovation-driven company focused on regulated market submissions.
- Exposure to international regulatory operations and global dossier compilation.
- Career growth in a professional and supportive environment.
- Be part of a team contributing to healthcare access and quality medicine delivery.
High CPC Keywords Used Naturally
pharmaceutical regulatory affairs jobs, dossier submission careers, B.Pharm openings, M.Pharm vacancies Mumbai, regulatory compliance pharma, eCTD submission jobs, pharma documentation jobs, pharmaceutical quality assurance, high-paying pharma careers, regulatory operations manager roles, Olive PharmaScience careers.
FAQs
1. Who can apply for these openings at Olive PharmaScience?
Candidates with a B.Pharm, M.Pharm, or M.Sc degree and 5–10 years of experience in Regulatory Affairs or Dossier Management.
2. What experience level is required?
Senior Executive (5–7 years) and Manager (8–10 years).
3. What is the work location?
The openings are based at Olive PharmaScience Ltd., Mumbai.
4. What markets are involved?
Candidates will handle regulated and ROW markets including USFDA, EMA, MHRA, and TGA.
5. How to apply?
Send your updated resume directly via DM or HR contact mentioned in the announcement.
Summary Table
| Category | Details |
|---|---|
| Company | Olive PharmaScience Ltd. |
| Vacancies | Senior Executive – Regulatory Affairs, Manager – Dossier Submission |
| Required Education | B.Pharm, M.Pharm, M.Sc (Pharmaceutical Sciences, Chemistry, Life Sciences) |
| Experience | 5–10 years (depending on role) |
| Location | Mumbai, Maharashtra |
