Regulatory Affairs Associate Level II

at  Bimeda

Reporting to the Regulatory Affairs Manager, the Regulatory Affairs Associate Level II is responsible for the day to day Regulatory Affairs activities within the Regulatory Affairs Department.

KEY ROLE SPECIFIC REQUIREMENTS:

• Prepare, compile, and submit, new product applications through national, mutual recognition, decentralised or centralised procedures.
• Prepare, compile and submit variation applications to support changes to authorised details and manage applications through to completion for national, mutual recognition, decentralised or centralised procedures.
• Prepare, compile and submit renewal applications in accordance with strict deadlines, and manage application through to completion.
• Update dossiers to mutual recognition standard and progress through national, mutual recognition, decentralised or centralised procedures
• Preparation of responses to queries from regulatory agencies on new and existing products in conjunction with relevant personnel.
• Collect, collate, and evaluate scientific data, and present the information in an organised format.
• Preparation and/or updating of product literature in accordance with regulatory and marketing requirements.
• Liaise with Regulatory Authorities and external customers/distributors.
• Interaction with partner companies, distributors and provision of the required documentation.
• Work closely with all departments, providing regulatory support for the operation and control of the facility.
• Contribute to cross-functional project teams.
• Clear communication with relevant departments regarding the changes in registered details.
• Update / maintain internal databases in relation to the status of on-going tasks.
• Provide regulatory compliance information within the company in relation to Change Control, Packaging Specifications, Product Literature, and Product Quality Review requirements.
• Filing and retrieval of regulatory information.
• Keep abreast of all regulatory legislation and trends in order to provide appropriate guidance / direction to internal and external stakeholders on all areas of regulatory compliance.
• Any other tasks as may be reasonable requested by the Regulatory Affairs Manager.

COMPETENCIES REQUIRED FOR THE ROLE:

• EFFECTIVE COMMUNICATION - Is the ability to convey information to another effectively and efficiently, to listen – help facilitate sharing of information between people. It is about understanding the emotional intention behind the information. The ability to express oneself clearly in conversations, confirm understanding, communicate using data and facts whilst adapting to one’s audience. Exhibit willingness to listen, and show respect for oneself and others in interactions with others. express oneself clearly in verbal and business writing.
• CREATIVITY AND INNOVATION - is the ability to create, develop and implement a new product, process or service with the aim of improving efficiency, effectiveness or competitive advantage. Also, the ability to transcend traditional ideas, rules, patterns, relationships, or the like, and to create meaningful new ideas, forms, methods, or interpretations.
• PLANNING – is the process of thinking about and organizing the activities required to achieve a desired goal.
• RESULTS ORIENTED – The ability to focus on the desired result of one’s own department’s work, setting challenging goals, focusing on the goals, and meeting or exceeding them.
• DECISIVENESS – The ability to make difficult decisions in a timely manner and avoid procrastinating or asking for unnecessary data or information. Makes the right decision, asks the right questions, finds solutions.

Essential:

• Bachelor’s Degree received in scientific area (Pharmacology, Chemistry, Biology, Veterinary or similar).
• At least 3-4 years’ Regulatory Affairs experience within the Pharmaceutical or related industry.
• Ability to perform via multitasking.
• Excellent attention to detail.
• Excellent verbal and written communication skills.
• Excellent organisational skills with the ability to prioritise and manage projects within a team environment.
• Good interpersonal skills, building strong working with relationships with stakeholders both internal and external.
• Self-motivated with the initiative and resourcefulness to successfully see projects through to completion.
• Proficient in the use of MS Office tools.