Regulatory Affairs Manager

Job Responsibilities


Coordinate the development and implementation of country product regulatory strategies in support of business objectives
Formulate and implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
Participate in project teams developing new products to define country regulatory requirements
Prepare accurate regulatory submissions to secure timely approvals in support of business initiatives
Monitor the development of impending and changes of regulations and standards. To communicate potential business impact to all appropriate levels of management.
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, and/or marketing of products.
Provide support to the Technical Manager to build capability in the business to ensure that regulatory requirements are considered throughout the product development and product sourcing processes. Conduct training seminars on regulatory requirements and/or impending regulations to the appropriate business team members to enable the best global development activities
Coordinate and maintain regulatory procedures to ensure consistent, efficient and compliant regulatory processes
Coordinate tracking information on regulatory approval in product registrations, preparation of product samples, document packages for regulatory submissions, audits with NAFDAC, SON and other relevant regulatory authorities.
Communicate appropriately with all customers, government, regulatory agencies and the business, conducting all communications and transactions with the utmost integrity and honesty.
Participate in the development and implementation of trial protocols.
Any other regulatory support assigned by the Technical Manager


Qualifications & Requirements


A bachelor's degree in a relevant discipline.
7 years’ work experience with at least 5years in a similar position.
Ability to withstand stress and pressure.
Experience as Quality personnel as well as experience in R&D and manufacturing will be an added advantage.



Click Apply button to apply »