Regulatory Affairs Officer at DKT International

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 tregulatory agencies.
• Liaise with relevant regulatory bodies tfollow 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 tensure compliance with regulatory standards.
• Provide guidance tmarketing and sales teams tensure that all promotional activities and communication materials are compliant.

Cross-functional Collaboration:

• Work closely with Marketing, Sales, and Supply Chain teams tensure 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 tsupport the product lifecycle.
• Provide insights on regulatory requirements for new market entries and contribute tplanning 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 tthe industry.
• Strong organizational skills and attention tdetail.
• Excellent communication skills for interacting with regulatory authorities and internal stakeholders.
• Ability twork 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.