Drug Regulatory Affairs (DRA) Head Vacancy in a multinational Pharmaceutical Company in Nigeria
A reputable
multinational Pharmaceutical Company in Nigeria is seeking a
qualified, experienced and dedicated individual to fill the position of a
Drug Regulatory Affairs (DRA) Head.
Job Title: Drug Regulatory Affairs (DRA) Head
Job Profile
Efficient
management of regulatory matters in the assigned country group, ensuring
registration milestones of global and regional/local projects are met and in
line with business and functional objectives. Successful maintenance of
existing licences. Input to regulatory strategies aligned with commercial and
Regional objectives. Regulatory functional excellence, including all compliance
related activities are achieved and maintained.
Main
Responsibilities and Duties
- New registrations
and approvals
- Licence
maintenance
- Local /Global
Database (or similar) maintenance
- DRA
Compliance
- Packaging
materials: owner of local packages
- Promotional
material validation and approval
- Leadership
and Management of Direct Reports (where applicable)
- Regulatory
Intelligence-managing the regulatory environment
- Business
awareness e.g.: applies business and commercial basic principles to effectively
support proposed regulatory strategies and Portfolio plans.
- DRA Budget of
assigned cluster
Key Performances
- Management of
Development Portfolio plans with regular and timely communication of performance,
and issues. Update of Portfolio development plans, or input into DASA tool.
- Achievement
of standard and stretch registration milestones/deliverables.
- Time to
market of new launches with competitive labelling.
- Completeness/accuracy
of the cluster Standard Requirements and timely communication to HQs on significant
changes.
- Effective
management and proactive communication of emerging regulatory changes with impact
to the assigned cluster/countries to respective local and global stakeholders.
- Ability to
drive and propose changes on regulatory emerging regulations with successful outcome
to the Organization.
- Successful
stakeholder management (internal and external)
- Successful
people development and talent retention
- Adequate
budget management and planning
- DRA
functional excellence and submission strategies
- Achievement
of Regulatory compliance deliverables as per global target
Qualification
& Experience
- Doctorate of
State in Pharmacy or similar degree in Life Science
- English
(Fluent), other languages such as French is desired but not mandatory
- Minimum of 6
years’ experience in Drug Regulatory Affairs, preferable at al Pharmaceutical
Industry or equivalent
- Experienced
leader proven successful management of people
- Excellent
communication and negotiation skills
- Strong result
driven, ability to bring innovative ideas, “think out of the box”
How to Apply
Interested and qualified candidates should
Click Here to Apply