Regulatory Affairs Officer at DKT International Nigeria

DKT International Nigeria is a social marketing organization whose core mission is the provision of safe and affordable options for family planning, reproductive health and HIV prevention. DKT International Nigeria is the largest private provider of family planning and reproductive health products and services in the developing world.

We are recruiting to fill the position below:

Job Title: Regulatory Affairs Officer

Location: Lagos
Employment Type: Full-time

Job Summary

• The Regulatory Affairs Officer is responsible for ensuring that products comply with all regulations and legislation within the respective markets.
• This role involves preparing and submitting documentation to regulatory authorities, maintaining compliance records, and assisting in the development of regulatory strategies to achieve timely approval and maintenance of products.

Key Responsibilities
Regulatory Submissions:

• Prepare, compile, and submit documentation for new product registrations, renewals, and variations to regulatory agencies.
• Liaise with relevant regulatory bodies to follow up on submission approvals and resolve any queries.

Compliance and Documentation:

• Ensure that all products comply with the local and international regulations.
• Maintain regulatory files and databases with up-to-date information on all products.
• Monitor changes in regulatory guidelines and keep internal teams informed about any updates.

Product Labelling and Advertising:

• Review and approve product labels, packaging, and promotional materials to ensure compliance with regulatory standards.
• Provide guidance to marketing and sales teams to ensure that all promotional activities and communication materials are compliant.

Cross-functional Collaboration:

• Work closely with Marketing, Sales, and Supply Chain teams to ensure compliance during product development and production.
• Assist with the regulatory review of materials and processes for product testing and trials.

Regulatory Strategy Development:

• Assist in the development and implementation of regulatory strategies to support the product lifecycle.
• Provide insights on regulatory requirements for new market entries and contribute to planning and risk assessments.

Regulatory Intelligence:

• Conduct research on regulatory trends, competitors’ product approvals, and emerging regulations.
• Maintain awareness of international regulations and industry practices that impact the company’s regulatory strategy.

Qualifications and Skills

• Bachelor’s Degree in Life Sciences (e.g., Biology, Chemistry, Pharmacy), Health Sciences, or a related field.
• Proven experience in regulatory affairs within [industry, e.g., pharmaceuticals, medical devices, or cosmetics].
• Minimum of 10 years of relevant experience in a similar position.
• Knowledge of regulatory guidelines and processes specific to the industry.
• Strong organizational skills and attention to detail.
• Excellent communication skills for interacting with regulatory authorities and internal stakeholders.
• Ability to work under pressure and manage multiple deadlines.

Additional Qualifications:

• Familiarity with NAFDAC processes, etc.
• Certification in Regulatory Affairs is a plus.
• Experience with electronic regulatory submission systems.

Salary
The compensation package is very attractive and includes performance-based incentives.

Application Closing Date
26th November, 2024.

Method of Application
Interested and qualified candidates should send their CV to: [email protected] using “Regulatory Affairs Officer” as the subject of the email.