Jobs

Regulatory Affairs Manager in a Pharmaceutical Company

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 position below:

Job Title: Regulatory Affairs Manager
Location: Lagos

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.
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.
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.

Requirements

Pharmacy Degree, An (MSc) may be an advantage but is not essential.
Minimum of 5 years appropriate Regulatory Experience.

Competencies:

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
Influencing
Interpersonal acumen
Organizational agility
Strong quality and compliance orientation
Negotiation skills
Understands Pharmaceutical Industry.
Understanding stakeholder needs.