Regulatory Affairs/Product Development Pharmacist
A Ghanaian-owned pharmaceutical company seeks to hire a Regulatory Affairs/Product Development Pharmacist to assist and support in implementing the overall development of new products, reformulation/optimization of existing products to meet current Good Manufacturing Practices (cGMP), Food and Drugs Authority (FDA), and International standards.
- Reports directly to the Product Development Manager.
- Takes appropriate directives from senior management.
- Support and coordinate the development, production, packaging and repackaging of solid and liquid products to meet set targets
- Ensure that all aspects of the development process on any new product in-house, products for reformulations/optimization and by contract manufacturers complies with cGMP and ISO requirements.
- Assist in preparing information flow in product formulation/reformulation from conception to manufacture or purchase of contract-manufactured products for sale.
- Ensure that all documents relating to development, packaging and repackaging of new or modified products are accurately and promptly filled, signed and delivered to the appropriate persons/places on time.
- Perform development trials, in-process control (IPC) tests and report accurately for decision making.
- Co-ordinate safety and housekeeping activities to ensure compliance with Food and Drugs Authority and company policies.
- Assist in scheduling resources both materials and human needed to ensure maximum productivity/efficiency.
- Assist in the preparation of Technical Dossier for product registration.
- Assist in Pharmacovigilance activities.
- Perform other regulatory functions.
- Assist in departmental planning which involves setting departmental objectives and collating metrics on them, departmental budget preparation, and development costing of products
- Assist in supervising subordinates in the area of daily scheduling of work, which includes; development of packaging materials such as; labels, jackets, alufoils, inserts etc.
- Assist in with appraisals and in-house training of subordinates in the area of product development cGMP and ISO guidelines.
- Assist in preparing product cost estimation (initial and final) in conjunction with accounts department.
- Perform other duties as assigned by the manager or senior staff.
Qualifications and Experiences
- Bachelor Degree in Pharmacy (B.Pharm/BSc.). A Masters’ degree in any area of pharmaceutical sciences will be an added advantage.
- 2- 5 years’ experience in a pharmaceutical or related industry OR equivalent work experience (minimum 7 years) in the pharmaceutical or related industry in lieu of formal education.
- Must have technical experience and knowledge of equipment and machines in the production of solids, liquids, sterile preparations, etc.
- Problem solving, leadership and delegation skills.
- Must have good communication skills.
- Must possess time management skills.
- Ability to operate independently.
Job type: Full-Time
Job status: Open to new applicants
Years of Experience:
Educational Level: University
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