Lorache Consulting Limited – Our client, a Pharmaceutical Company with a wide range of pharmaceutical/health care products is seeking to recruit career-minded, target driven, focused, experienced, and honest professional to fill the vacant position of:
Job Title: Regulatory Affair Manager
- 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.
- Pharmacy Degree, an (M.Sc) may be an advantage but is not essential.
- Minimum of 5 years’ appropriate Regulatory Experience.
- 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
- Interpersonal acumen
- Organizational agility
- Strong quality and compliance orientation.
Interested and qualified candidates should send their CV to: [email protected] using the Job Title as the subject of the email.
Application Deadline: 20th July, 2021.