About Company
Fidson Healthcare Plc is a leading pharmaceutical company in Nigeria, committed to providing high-quality, affordable healthcare solutions. We are a dynamic and growing organization with a strong focus on innovation and a commitment to our employees’ professional development. We strive to create a positive and supportive work environment where our team members can thrive and contribute their best.
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Job Description
We are seeking a highly motivated and experienced Regulatory Affairs Specialist to join our expanding team in Apo, Abuja. The successful candidate will be responsible for ensuring compliance with all relevant regulatory requirements for our pharmaceutical products throughout their lifecycle. This involves a wide range of activities, from pre-submission planning and documentation to post-market surveillance and product lifecycle management. You will play a pivotal role in navigating the complex Nigerian regulatory landscape, ensuring timely and efficient approvals, and maintaining compliance across all relevant agencies. You will work closely with internal cross-functional teams, including research and development, manufacturing, and marketing, to ensure that our products meet the highest standards of quality and regulatory compliance. The ideal candidate will be a strategic thinker with strong problem-solving skills, excellent communication skills (written and oral), and a deep understanding of the Nigerian pharmaceutical regulatory environment. This role requires a highly organized individual capable of managing multiple projects simultaneously and effectively meeting tight deadlines. You must be comfortable working both independently and collaboratively as part of a dynamic team.
Key Responsibilities
- Develop and implement regulatory strategies for new and existing products.
- Prepare and submit regulatory submissions (e.g., INDs, NDAs, variations) to relevant agencies.
- Manage regulatory interactions with Nigerian regulatory authorities (NAFDAC and others).
- Maintain up-to-date knowledge of relevant regulations and guidelines.
- Conduct post-market surveillance and manage product lifecycle management activities.
- Prepare and maintain regulatory documentation.
- Represent the company at regulatory meetings and conferences.
- Collaborate with internal cross-functional teams.
Required Skills
- In-depth understanding of Nigerian pharmaceutical regulations (NAFDAC).
- Experience in preparing and submitting regulatory submissions.
- Strong communication and interpersonal skills.
- Excellent organizational and time management skills.
- Proficiency in Microsoft Office Suite.
- Strong problem-solving skills.
Preferred Qualifications
- Bachelor's degree in Pharmacy, Pharmacology, or a related field.
- Minimum of 3 years of experience in regulatory affairs within the pharmaceutical industry in Nigeria.
- Experience with post-market surveillance and product lifecycle management.
- Membership of relevant professional bodies (e.g., PSN).
Perks & Benefits
- Competitive salary and benefits package.
- Health insurance.
- Professional development opportunities.
- Opportunities for career advancement.
How to Apply
Click on the link below to apply for this exciting opportunity. Please submit your CV and cover letter outlining your relevant experience and qualifications.
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