Dy. Manager/ Assistant Manager - Regulatory Affairs
- Opes Healthcare
- 7 - 12 years
- Ahmedabad
- 9 hours ago
- Email to a friend
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Job Description
Role & responsibilities
Assistant Manager/ Dy. Manager Regulatory Affairs (CIS, LATAM & Africa Markets)
Role Purpose
Ensure timely, accurate, and compliant regulatory submissions and approvals across CIS, LATAM, and Africa markets. The role drives dossier lifecycle management, regulatory data integrity, digital systems, and team performanceensuring uninterrupted product approvals and lifecycle compliance in line with regional and global standards.
Key Responsibilities
1. Dossier Lifecycle Ownership
- Manage end-to-end dossier lifecycle across CIS, LATAM, and Africa in line with regional regulations (e.g., EAEU and country-specific guidelines).
- Review and approve dossiers prior to submission.
- Ensure timely submissions for registrations, variations, renewals, and amendments.
2. Regulatory Query & Approval Management
- Track and coordinate responses to regulatory authority queries across regions.
- Liaise with health authorities and local agents/distributors for faster approvals.
- Monitor timelines and proactively resolve approval bottlenecks.
3. Regulatory Data & Documentation Control
- Maintain a structured, audit-ready regulatory database across all regions.
- Ensure documentation accuracy, control, and accessibility.
- Uphold data integrity, version control, and traceability.
4. Systems & Automation
- Manage digital tools for dossier tracking, approvals, and reporting.
- Maintain real-time dashboards for submission and approval status.
- Drive continuous improvement in regulatory workflows and efficiency.
5. Team Management & Capability Development
- Allocate dossiers based on workload, complexity, and business priorities.
- Train and mentor team on multi-region regulatory requirements.
- Build team capability to handle diverse regulatory environments.
6. Compliance & Governance
- Ensure compliance with CIS, LATAM, and Africa regulatory requirements and internal SOPs.
- Monitor adherence to governance frameworks and audit readiness.
- Support inspections with complete and accurate documentation.
7. Reporting & Communication
- Prepare and present regulatory performance updates to management.
- Provide visibility on submissions, approvals, risks, and challenges across regions.
- Act as a key liaison between internal teams and regional stakeholders.
THANKS YOU
REGARDS
MILAP RATHOD (7486829***)
HR DEPARTMENT
OPES HEALTHCARE PRIVATE LIMITED
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Legal & RegulatoryRole Category: Corporate AffairsRole: Corporate Affairs - OtherEmployement Type: Full timeContact Details:
Company: Opes HealthcareLocation(s): Ahmedabad
Keyskills: Regulatory Affairs Drug Regulatory Affairs CTD Dossier Preparation Submission Row Market Dossier Compilation Actd Ectd RA Regulatory Submissions
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