Senior Manager – Regulatory Affairs (ROW Markets)
ACME Group
- Location
- Nalagarh, Himachal Pradesh, India
- Job type
- Full-time
Required skills
- compliance
- cross-functional
- product lifecycle
- ERP
About the role
ACME Group
Website:
acmegenerics.in
Job details:
Key Responsibilities
- Review registration dossiers in coordination with technical functions and in/out-licensing partners to ensure compliance with current regulatory requirements of ROW markets.
- Ensure consistency, completeness, and adequacy of regulatory submissions in line with applicable regulations and agency expectations.
- Provide strategic regulatory guidance for pre-approval and post-approval activities, including submissions, approvals, and regulatory commitments.
- Coordinate with regulatory authorities on bioequivalence requirements, recommendations, and inactive ingredient levels during product development.
- Ensure timely preparation and submission of responses to regulatory deficiencies and queries.
- Lead and manage the Regulatory Affairs team, allocate responsibilities, and ensure timely completion of submissions and regulatory activities.
- Coordinate with internal stakeholders and third-party/contract manufacturing partners to resolve regulatory and submission-related delays.
- Manage product lifecycle activities, including renewals, variations, post-approval changes, change controls, and regulatory filings, ensuring product continuity.
- Review and approve regulatory aspects of change controls and ensure timely filing and approval of variations across ROW markets.
- Manage regulatory activities including regulatory updates, NDC, drug listing, dossier compilation, filing/submission, query responses, CARES Act requirements, and coordination of pharmacovigilance activities.
- Ensure continued product compliance with approved dossiers, applicable regulations, and regulatory commitments.
- Review, provide comments, and ensure closure of QMS documents, including Change Controls, Deviations, Incidents, and CAPAs in EQMS.
- Ensure timely and effective execution of regulatory-related activities in ERP, LIMS, eLog, AMS, and LMS systems.
- Coordinate and deliver regulatory training programs through the Learning Management System (LMS).
- Monitor and manage RSI updates based on PRAC recommendations and other applicable regulatory authority requirements.
- Track regulatory changes and assess their impact on existing products, dossiers, and submission strategies.
- Establish effective coordination with Quality, R&D, Clinical, Pharmacovigilance, Manufacturing, Supply Chain, and other cross-functional teams to ensure regulatory compliance and business continuity.
- Drive continuous improvement of regulatory processes, submission quality, compliance, and overall regulatory readiness.
Desired Competencies
- Strong knowledge of regulatory requirements and submission processes for ROW markets.
- Expertise in dossier review, lifecycle management, variations, renewals, and regulatory submissions.
- Strong understanding of regulatory compliance, QMS, pharmacovigilance coordination, and post-approval requirements.
- Excellent team management, stakeholder coordination, communication, and problem-solving skills.
- Ability to manage multiple regulatory projects and submissions within defined timelines.
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