Senior Responsible Pharmacist / Regulatory

SUMMARY:
A well-known established pharmaceutical manufacturing company requires the above to manage and oversee all regulatory pharmaceutical scheduled and controlled products supplied into the pharmaceutical manufacturing and related markets for the company.

POSITION INFO:
Minimum requirements for the role:

• A B Pharm degree registered with South African Pharmacy Council is essential for this role.
• Previous experience having worked in a Responsible Pharmacist role having worked closely with SAHPRA is essential for the role.
• Previous experience having managed and handled all regulatory aspects within a pharmaceutical manufacturing or related market is essential for the role.
• Must have the ability to meet deadlines.
• Must have good communication and Excel skills.

• Managing and overseeing all regulatory pharmaceutical scheduled and controlled products supplied into the pharmaceutical manufacturing and related markets for the company.
• Working closely with senior management to ensure that all regulatory matters are handled correctly and timeously.
• Working closely with the companies customers to ensure that all products that are imported are SAHPRA compliant.
• Ensuring high standards of pharmaceutical care in accordance with good practice and other legal requirements.
• Ensuring compliance with the legislative requirements as set out in the Medicines and Related Substances Act 101 of 1965 and Pharmacy Act 53 of 1974 as well as all applicable legislative requirements for the company’s product portfolio and all regulations and guidelines pertaining to the import/ export license for medicinal products and good manufacturing practices.
• Ensuring compliance with statutory/regulatory requirements of the various authorities in South Africa and related authorities in other African countries where products are sold.
• Prove regulatory intelligence and advice to the business with regard to regulatory changes affecting the importation and exportation of the products.
• Responding to requests adequately, satisfactorily and timeously for external customers.
• Investigating and reporting on customer complaints as per local and company requirements.