• The Senior Regulatory Adviser – Pharmacist will work closely with the General Manager - Field Operations, but reports directly to the Country Director and is accountable for the preparation and management of simple and complex regulatory submissions.
• The incumbent will work independently and within a group setting to act as a liaison between Regulatory affairs and other functional Ares including external regulatory body, partners and consultants in the planning, organising and the preparation of regulatory documents for submission to government regulatory agencies.
• The individual will have a solid understanding of FDA regulations and GSA guidance and Experience with regulatory submissions, including INDs, international clinical trial applications and marketing applications in Common Technical Document format.
• The ideal candidate will have excellent written and verbal communication skills, proficient in project management, be flexible, and able to work in a fast-paced environment where accuracy and speed are paramount. Specific Duties and Responsibilities: Reporting to the country Director, the Senior Regulatory Advisor (Pharmacist) will:
• Actively lead the development of new products and implementation of regulatory strategies for assigned projects
• Lead the registration of new commodities / drugs with the FDA
• Timely compile materials for license renewals, updates and registrations
• Maintain regulatory files / database and chronologies in good order. Establish and maintain system for tracking changes in documents submitted to agencies or partners
• Prepare, coordinate, manage or maintain simple and complex regulatory submissions (e.g. INDS, CTAs, amendments, safety reports, DSUR, annual reports, meeting packages etc.) in accordance with applicable regulations, this includes ability to translate regulatory requirements into practical, workable submission plans: develop & maintain timelines, coordinate internal/external authoring/review/comment adjudication and finalisation (submission and archival)
• Provide thoughtful & accurate comments during document review (e.g IB, protocal, ICFs, DSURs, annual reports, etc) mindful of regulatory groups (e.g. CRO, partner, consultants, etc) mindful of regulatory/ICH guidance/requirements pertaining to document content.
• Interface with external regulatory groups (e.g CRO, partner, consultants, etc) in the preparation/review/compilation/finalisation/submission/posting of regulatory submissions, including IDNs, international clinical trial applications and marketing applications in Common Technical Document format, is essential.
• Ability to handle multiple assignments and good judgement in prioritising tasks
• Demonstrated ability to work independently and within a group setting, and to interact with various departments and functional groups
• Ability to push regulatory bodies to meet deadlines (Keeping accurate records of all interactions with regulatory authorities, manufacturers and supplies)
• Strong communication skills and highly influential and the ability to identify and recommend solutions to problems
• High level of attention to detail, and proficient in Microsoft Office applications, Adobe and Excel
• Liaison between the company and the Pharmaceutical council, FDA and other regulatory authorities Core Job Responsibilities:
• Represent Regulatory Affairs on DKT product development to ensure all regulatory requirements are met throughout the development process
• Complete submission on FDA and GSA regulatory entities
• Create and maintain product technical files.
• Review advertising and marketing materials for appropriateness and compliance to regulatory requirements and laws.
• Supervise Regulatory Affairs consultants as required
• Other duties as assigned. Qualification Required & Experience
• Must have at least 10 years experience in similar position.
• Advance degree with at least B. Pharm from a top recognised university.
• Experience in dealing with the FDA, Ghana Standards Board, Pharmaceutical Council and associated regulatory bodies. Location:
Accra How To Apply For The Job
Interested and qualified applicants should send a one-page motivational statement and CV to: [email protected] Closing Date:
26 May, 2016