Job Summary
As the Regulatory Affairs Associate you will ensure the compliant registration of new and maintain registration of existing drugs according to global registration requirements whilst developing regulatory project strategies.
Responsibilities
Strategic planning and co-ordination of submission of drug registration applications in a timely manner and follow through the application during the evaluation phase to achieve approval in line with planned registrations
To ensure that documents for new registration and re-registration are got to ensure submission is achieved by due dates
To ensure that submissions for license renewal are done in good time before license expiry so as to achieve approvals and to avoid top line impact due to license expiry.
To enhance and facilitate approval of new products and re-registration of already approved products as at when due.
Requirement/Competencies
At least 3 years experience of a broad range of regulatory work in the Pharmaceutical industry.
Capable of working independently and creatively to achieve objectives.
Ability to direct and lead a team when required to do so to meet goals and timescales dictated by the market demand.
Technical competence and good problem solving and analytical skills.
Ability to communicate effectively.
Good inter-personal skills to establish and develop working relationships internally and externally.
Ability and willingness to travel and attend meetings and seminars to keep abreast of current and future regulatory requirements.
Qualified and interested candidates should kindly forward their CV’s to: cv@bsr.re
Apply via :
cv@bsr.re
