Regulatory Affair Manager Vacancy at a Pharmaceutical Company – Lorache Consulting Limited

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About the role

Regulatory Affair Manager job opportunity is available at Lorache Consulting Limited for individuals who possess relevant qualifications.

Responsibilities

• Interaction and co ordination with pharmacy practice and regulatory bodies/agencies (SON,NAFDAC,PCN etc)
• Ensuring that regulatory requirement are complied with to the satisfaction of the relevant agencies.
• Guiding company to comply with regulatory requirements.
• Participating in advocacy and public corporate responsibility
• Make sure clear lines of accountability exist and that retrievable audit trails for documentations relating to operation of the company are kept.
• Make sure all professional activities undertaken by you or under your control are covered by adequate professional indemnity cover.
• Declare to the relevant person or authority any interest that could be perceived to influence your judgment which may impact on your regulatory activities.
• Development and registration of imported formulations and other pharmaceutical products.
• Regular warehouse inspection.
• Coordination of import of finished formulations, active pharmaceutical ingredients (APIs) and other medical/pharmaceutical products.
• Registration of premises of DPHL for distribution and wholesale when required.
• Registration/Renewal of DDL & DPHL products.
• Handling of compliance issues relating to the import and registration of imported products.

Experience and qualifications

• Pharmacy Degree, an (M.Sc) may be an advantage but is not essential.
• Minimum of 5 years’ appropriate Regulatory Experience.

Competencies Required:

• Knowledge of the Local regulatory environment and how this impacts regulatory strategy and implementation.
• Knowledge of drug development practice, rules, regulations, and guidelines.
• Communication skills
• Negotiation skills
• Understands Pharmaceutical Industry
• Understanding stakeholder needs
• Influencing
• Interpersonal acumen
• Organizational agility
• Strong quality and compliance orientation.

Application deadline

Application details