To support the Director of Regulatory and Scientific Affairs in ensuring regulatory and legal compliance. Also, expected to assist in following up pre-clinical research conducts by Contract Research Organization (CRO) and university collaborators.

Primary Responsibilities:

• ensuring that BCT’s drug development program and products comply with the relevant regulations;
• assisting in the area of investigational new drug and new drug application
• keeping up to date with international legislation, guidelines and customer practices in all countries that the company has an interest;
• collecting, collating and evaluating scientific data that has been researched by CROs;
• developing and writing clear arguments and explanations for new product licences and licence renewals;
• preparing submissions of licence variations and renewals to strict deadlines;
• monitoring and setting timelines for licence variations and renewal approvals;
• working with specialist computer software and resources;
• writing clear, accessible product labels and patient information leaflets;
• planning and developing product trials and interpreting trial data;
• advising scientists and manufacturers on regulatory requirements;
• undertaking and managing regulatory inspections;
• reviewing company practices and providing advice on changes to systems;
• participating in liaison with, and making presentations to, regulatory authorities;
• participating in negotiation with regulatory authorities for marketing authorisation;
• specifying storage, labelling and packaging requirements.
• carrying out any other relevant responsibilities and/ or functions of the Group, as assigned from time to time.

Skills and Qualifications:

• Graduate qualification in Biochemistry, Life Sciences or Pharmaceutical Sciences.
• Preference will be given to candidate with experience in drug development.
• Excellent verbal and written communication skills, experience with regulatory and scientific technical writing and drafting SOPs advantage.
• Able to work flexible schedules on short notice.

We are located in Science Park with a 5 days’ working week and provide medical insurance.

Interested parties please email your resume with current and expected salary by clicking "Apply Now"