Regulatory Affairs Manager
Adexen
Nigeria
9d ago

Job description

The Regulatory Affairs Manager is responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements.

Responsibilities :

  • Create and maintain contacts with Ministry of Health and organizations participating in registration, expertise and quality control of medicinal products in Nigeria.
  • Monitor registration requirements, quality assurance, product maintenance of medicinal products and inform the Head of Regulatory Affairs and all departments on changes connected with product portfolio promotion and sales.
  • Carry out all activities pertaining to registration and maintenance of product portfolio, subsidiaries and company partners as defined by Head of Regulatory Affairs.
  • Ensure adherence to industry-specific codes of practice, advertising codes, regulatory directives and guidelines as applicable to the role and Programs for Legal Compliance and Corporate Responsibility of the company.
  • Participate in development and implementation of packaging, labelling and application instructions.
  • Check conformity of NDA, include relevant corrective amendments and provide the links between Product supply and Regulatory Affairs functions.
  • Support projects of business units through review and approval of promotional material; ensure the company promotional material comply with the company and local country requirements.
  • Ensure product supply chain compliance as well as the local quality representation.
  • Expectations

  • Bachelor's degree in Pharmacy
  • Minimum of 8 years’ cognate experience in pharmaceuticals.
  • Good knowledge of legislative and other standard documents in the sphere of registration and certification of pharmaceutical products
  • Analytical and conceptual thinking;
  • Have strong communication skills and able to work closely with people in a wide variety of disciplines at different levels within the organization
  • Capable of representing the interests of the company effectively to a range of regulatory agencies and government officials.
  • A self-starter, systematic, hands-on and thorough with a goal-oriented mindset.
  • Knowledge in developing protocols and analyzing data reports for registration requirements.
  • Experience in compiling accurate and complete preparation of registration dossiers.
  • Apply
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