Your new company

Your new role

• Prepare, compile, and submit, new product applications through national, mutual recognition, decentralized or centralized procedures.
• Prepare, compile and submit variation applications to support changes to authorized details and manage applications through to completion for national, mutual recognition, decentralized or centralized 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, decentralized or centralized 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 organized 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.

What you'll need to succeed

• Bachelor’s Degree received in scientific area Pharmacology, Chemistry, Biology, Veterinary or similar.
• 3-4 years’ Regulatory Affairs experience within the Pharmaceutical or related industry.
• Excellent verbal and written communication skills.
• Excellent organizational skills with the ability to prioritize and manage projects within a team environment.
• Strong 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.
• Previous experience within the Agri / Veterinary Industry would be advantageous.

What you'll get in return

• This would be a permanent position with excellent security and competitive benefits.
• The opportunity to gain broader insight into the overall regulatory process as it will be working within a small compact team of professionals.

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.