Regulatory Affairs Specialist at Best Search Recruitment

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.