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Regulatory Affairs Manager at Ascentech Services Limited

Ascentech Services Limited
September 08, 2026
Full-time
On-site
Job Summary


We are seeking an experienced and highly knowledgeable Regulatory Affairs Manager to lead regulatory compliance and product registration activities within our organization.


Responsibilities


Regulatory Affairs & Product Registration
Develop and implement regulatory strategies for new product registrations, renewals, variations, and approvals.
Prepare, compile, and submit regulatory dossiers and supporting documentation to NAFDAC and other relevant regulatory bodies.
Monitor submission timelines, registration status, license expirations, renewals, and variations.
Ensure regulatory documentation is accurate, complete, and submitted within required timelines.
Act as the key liaison with NAFDAC, SON, and other relevant regulatory authorities.


Regulatory Compliance:


Monitor changes in Nigerian regulatory laws, guidelines, standards, and policies and advise management accordingly.
Ensure products, labels, packaging, and promotional materials comply with applicable regulatory requirements.
Coordinate regulatory requirements during inspections, audits, and compliance reviews.
Ensure timely processing and renewal of regulatory licenses and permits.
Identify potential compliance risks and implement appropriate corrective actions.


Cross-Functional Collaboration:


Work closely with Quality Assurance, Production, R&D, Supply Chain, Sales & Marketing, Legal, and other relevant departments.
Provide regulatory guidance throughout the product lifecycle.
Support import/export documentation and regulatory requirements for regulated products.
Coordinate post-market surveillance activities, including product complaints, adverse events, and recalls where applicable.


Strategy & Team Leadership:


Develop and execute regulatory affairs strategies aligned with business objectives.
Establish efficient regulatory processes and systems.
Lead, mentor, and develop the regulatory affairs team.
Delegate responsibilities effectively and ensure timely decision-making.
Support performance management and promote a collaborative, high-performing team culture.


Requirements


Bachelor's degree in Pharmacy, Industrial Chemistry, Engineering, or a related field.
5 - 8 years of relevant experience in Regulatory Affairs, preferably within Nigeria.
Proven experience managing NAFDAC product registrations, renewals, variations, and regulatory submissions.
Strong knowledge of NAFDAC guidelines, SON standards, and other applicable Nigerian regulatory frameworks.
Experience in a supervisory or managerial regulatory affairs position is preferred.
Knowledge of ECOWAS/African regulatory requirements is an added advantage.
A Master's degree or relevant postgraduate qualification is an advantage.

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