Opes Healthcare Hiring Assistant Manager, Deputy Manager – Regulatory Affairs

B.Pharm/M.Pharm Regulatory Affairs Openings | Opes Healthcare

Apply for Assistant/Deputy Manager Regulatory Affairs at Opes Healthcare. 6–10 years exp. required. Location: Head Office. Apply today!

Opes Healthcare Pvt. Ltd., a fast-growing pharmaceutical company, is inviting applications for experienced professionals in Regulatory Affairs. This opportunity is ideal for candidates with strong expertise in dossier preparation and pharmaceutical documentation who are looking to take the next step in their career.

Company Overview

Opes Healthcare Pvt. Ltd. is a leading name in the pharmaceutical industry, recognized for its commitment to quality healthcare solutions across global markets. With an expanding portfolio of solid oral and injectable dosage forms, the company emphasizes regulatory excellence, compliance, and global healthcare advancement.

Job Role & Responsibilities

As an Assistant Manager/Deputy Manager – Regulatory Affairs, you will:

• Lead the Regulatory Affairs team handling dossier preparation in CTD and ACTD formats
• Conduct final reviews of dossiers before submission
• Review product artworks per regulatory authority guidelines
• Coordinate with F&D, QA, QC, and Stores departments for documentation
• Ensure compliance with pharmaceutical regulatory requirements and guidelines
• Collaborate with technical teams for dossier-related documentation
• Oversee regulatory submissions for CIS and LATAM markets

Eligibility / Qualifications

• Qualification: B.Pharm / M.Pharm
• Experience: 6–10 years in Regulatory Affairs
• Specialized Skills:
  • Strong knowledge of CTD & ACTD dossier formats
  • In-depth understanding of pharmaceutical documentation
  • Hands-on experience with CIS and LATAM submissions
  • Exposure to both solid oral and injectable dosage forms

Location & Salary

• Location: Head Office (India)
• Salary: Competitive package based on experience and qualifications

Application Process

Interested candidates are encouraged to apply early to secure their chance at this prestigious opportunity.

• Email: career@opeshealthcare.com
• Contact: +91 8511849377
• Website: www.opeshealthcare.com

Apply before 23rd August 2025 to secure your spot!

FAQs

Q1: What is the experience requirement for this role?
Candidates should have 6–10 years of experience in Regulatory Affairs, with proven expertise in dossier preparation and pharmaceutical regulatory guidelines.

Q2: Which markets will the candidate primarily handle?
This role is focused on CIS and LATAM regions, requiring experience with regulatory submissions for these markets.

Q3: What dosage forms does this role cover?
The position involves exposure to solid oral and injectable dosage forms.

Q4: How can I apply for this position?
Interested applicants can email their CVs to career@opeshealthcare.com or contact +91 8511849377.

Q5: Is this opportunity open for freshers?
No, this is a mid-senior level role requiring significant prior experience.

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