Regulatory Affairs Manager (Pharmaceutical Company) at Sigma Consult

About Our Client:

Our client is a leading pharmaceutical company based in Lagos, Nigeria, dedicated to ensuring compliance with regulatory requirements and standards for pharmaceutical products. With a focus on quality and safety, our client plays a crucial role in bringing safe and effective medications to patients.

Role Summary:

As a Regulatory Affairs Manager at our client's pharmaceutical company, you will be responsible for overseeing regulatory compliance activities and ensuring adherence to local and international regulations. You will play a key role in obtaining and maintaining regulatory approvals for pharmaceutical products and supporting product development and commercialization efforts.

Responsibilities:

• Develop and implement regulatory strategies to support the registration and approval of pharmaceutical products in Nigeria and other markets.
• Prepare and submit regulatory submissions, including marketing authorization applications, variations, renewals, and post-approval submissions, ensuring compliance with regulatory requirements and timelines.
• Liaise with regulatory agencies, including the National Agency for Food and Drug Administration and Control (NAFDAC), to facilitate the review and approval of regulatory submissions and address regulatory queries and requests.
• Stay abreast of changes in regulatory requirements, guidelines, and legislation affecting the pharmaceutical industry, and communicate relevant updates to internal stakeholders.
• Provide regulatory guidance and support to cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Marketing, to ensure compliance with regulatory requirements throughout the product lifecycle.
• Review and approve promotional materials, labeling, and product documentation to ensure compliance with regulatory standards and requirements.
• Manage regulatory compliance activities, including product registrations, licenses, permits, and inspections, and maintain regulatory documentation and records.

Requirements:

• Bachelor's degree in Pharmacy, Chemistry, Life Sciences, or related field.
• Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry, with a strong understanding of regulatory requirements and processes in Nigeria.
• Proven experience in preparing and submitting regulatory submissions for pharmaceutical products, including new drug applications (NDAs), ANDAs, and variations.
• Knowledge of Nigerian and international regulatory frameworks, including ICH guidelines, cGMP regulations, and pharmacopoeial standards.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders.
• Strong project management and organizational skills, with the ability to manage multiple priorities and deadlines.

Benefits:

• Competitive salary package.
• Opportunities for professional development and career advancement.
• Supportive work environment with opportunities for learning and growth.
• Comprehensive benefits package including health insurance and retirement benefits.
• Opportunity to contribute to the development and commercialization of pharmaceutical products.