Regulatory Affairs Manager at Ascentech Services Limited

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.