Company Name: Clicks

Post: Regulatory Pharmacist

Closing Date: 2015-04-28

Job Purpose:

To create, improve and develop the technical and specialised skills required to run a competent and successful in-house regulatory department that will ensure and secure the success of Unicorn Pharmaceuticals compliance and applicancy status.

Job Objectives:

• To take full responsibility and accountability in managing all the tasks related to, within the guidelines and regulations of the MCC, to comply and maintain the dossiers day to day by continuously liaising with the manufacturing sites and to ensure no changes are made without the necessary supportive data.
• To compile, submit, evaluate and manage all Unicorn dossier requirements, approvals and changes with the appropriate regulatory bodies (MCC) by coordinating with Unicorn suppliers (manufacturers, dossier owners, external regulatory consultants, etc.) to ensure timely resolution of issues, registrations and approvals by the regulatory authorities (MCC).
• To compile due diligence reports on potential and new dossiers as and when requested.
• To compile registration submissions in neighbouring countries as and when required
• To prepare, submit and monitor new applications and variations on both complementary and generic products to the MCC and other regulatory authorities on a regular basis
• To actively complete CTD conversions as per allocated time table
• To ensure amendment schedules are up to date.
• To evaluate and interpret bio studies in line with current MCC guidelines
• To initiate and interpret comparative dissolution studies for new products and formulation changes
• To assist with obtaining regulatory authority approvals for API and manufacturing site changes
• To interact with 3rd party suppliers regarding master documentation and other technical matters
• To initiate and manage change control procedures for registered products.
• To ensure product portfolios are maintained and updated on the electronic database and paper copies available for inspection
• To ensure all PI-PIL safety updates submitted as per allocated time table
• Responsible for reviewing and approving the Unicorn product packing design process and promotional material by ensuring all elements conform to the Marketing code and MCC guidelines.
• Assist Marketing with scientific product related information as and when required
• Assist with vendor inspections as and when necessary.
• To manage Pharmacoviligence processes for Unicorn products of the appropriate regulatory bodies & Unicorn suppliers.
• To keep abreast of new pharmaceutical and regulatory trends (dosage forms, active ingredients, regulatory changes) across the industry.
• To be hands on, eligible and responsible to take up the task of deputy Responsible Pharmacist at Unicorn Pharmaceuticals.

Job Requirements:

Qualifications and Experience:
• B. Pharm Degree, registered with the SA Pharmacy Council and in good standing (essential)
• At least 5-7 years working experience in a regulatory environment within the pharmaceutical industry.
• Medicine Registration Course essential
Skills, Abilities and Job Related Knowledge:
• Project Management, Planning and highly Organizing skills
• Computer literate and able to effectively use Excel and Word and applicable software
• Knowledge of generic pharmaceutical market
• Knowledge of registrations in other African countries
• Pharmaceutical Industry Laws, Regulations and ethics (Medicines and Pharmacy Acts)
• Other Industry related laws, Regulations and ethics (CPA, Companies and Competition Acts)
• Medicine Control Council Codes
• Business processes
• Knowledge of Pharmaceutical Manufacturing, Wholesaling/Distribution
• Policy and Procedure Development skills
• Legal Compliance skills
• Analytical and Problem solving skills
• Communication skills, both verbal and effective writing
• People & Relationship building skills
• Presentation skills

Essential Competencies:
• Adhering to Principles and Values
• Applying Expertise and Technology
• Deciding and Initiating Action
• Planning and Organising
• Delivering Results and Meeting Customer Expectations

How to apply:

Go here to apply.