A Reputable Pharmaceutical Company is seeking to recruit a suitable, motivated and results oriented Person for the Position below.

JOB TITLE: REGULATORY AFFAIRS PHARMACIST /OFFICER

REPORTS TO:GM PRODUCT DEVELOPMENT &REGULATORY AFFAIRS

JOB PURPOSE

• Regulatory affairs officers shall act as a link between the company and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation.

KEY RESPONSIBILITIES

• gathering, evaluating, organizing, managing and collating information in a variety of formats about company products.
• ensuring compliance with regulations set by the Medicines and Healthcare products Regulatory Agency (FDA)
• maintaining familiarity with company product ranges
• planning, undertaking and overseeing product trials and regulatory inspections
• keeping up to date with changes in regulatory legislation and guidelines and advice company appropriately.
• analyzing complicated information, including trial data
• ensuring the maintenance/ updating of product registrations and company trademarks in accordance with the relevant legislation, regulations and guidelines.
• obtaining marketing Authorization for company products.
• outlining requirements for labelling, storage and packaging
• liaising and negotiating with regulatory authorities
• providing advice about regulations to Phyto-Riker
• writing comprehensible, user-friendly, clear product information leaflets and labels
• ensuring that quality standards are met and submissions meet strict deadlines
• preparing, reviewing, and compiling Technical Dossiers for product registration.
• assisting in performing quality checks/ evaluation of all artworks and printed packaging materials.
• making regulatory submissions i.e., document and non-document deliverables to appropriate regulatory agencies.
• performing Pharmacovigilance activities (patency /literature search, training of staff involved in drug safety, preparation and reviewing of SOPs and other regulatory documents and records management).
• Performs other duties as assigned by the manager or senior staff.

COMPETENCIES

• Good Report writing and presentation skills.
• Analytical and problem-solving skills.
• Strong data gathering and Information management abilities.
• Ability to work for extended hours and with very minimal supervision.
• Ability to break complex work into simpler manageable tasks for effective execution.
• Responsive, reliable, and accountable.
• Strong computer literacy skills – MS Office Applications (Word, Excel, PowerPoint and Outlook).

Qualification Required & Experience

Educational Qualification and Relevant Experience

• Bachelor Degree in Pharmacy, Biological Sciences, Biochemistry, Biomedical science or Pharm D Plus 2-3 years’ experience in a pharmaceutical regulation or food regulation OR Diploma in Pharmaceutical Technology plus minimum 3 years’ experience in a pharmaceutical or related industry.
• Have a technical experience and knowledge of pharmaceutical equipment and processes.
• IT and Presentation skills
• Negotiation skills
• Analytical skills
• Time management skills
• Problem-solving skills
• Interpersonal skills
• Communication skills

Location: Accra