Regulatory Affairs Senior Scientist
Please Note: The application deadline for this job has now passed.
Job Introduction
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra.
We are a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business.
The Opportunity
The Regulatory Affairs Senior Scientist (South Africa) is the Responsible Pharmacist for the Dechra Veterinary Products SA (Pty) Ltd Affiliate (DVP SA) and is therefore responsible to carry out all duties, tasks and responsibilities of that position. (inclusive of Regulatory, Quality and Pharmacovigilance).
The Regulatory Affairs Senior Scientist (South Africa) is also responsible for submissions, maintenance and renewals for all the products for which DVP SA is the MA holder, even if outside South Africa.
The Regulatory Affairs Senior Scientist (South Africa) is also responsible for any needed interactions with any Regulatory or Statutory body and 3rd parties as needed in order to maintain the compliance status of the affiliate.
Main Responsibilities
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
- Ensuring all Legal requirements for the DVP SA Affiliate are adhered to in respect of Regulatory Requirements as a Pharmacy.
- Ensure that all requirements with regards to any products that DVP SA is the MA holder are adhered to and met (inclusive of product batch-release when needed).
- Ensure that all Personnel-related activities needed to be adhered to as the Responsible Pharmacist, including relevant legal documentation access, training and SOP’s are met.
- Ensure that all quality documentation, such as SOP’s, quality manuals, master documents are up to date and authorised.
- Ensure that periodic Product Quality Reviews are performed when needed.
- Ensure proper responses to inspections/ audits by any official bodies.
- Knowledge of regulatory legislation and registration procedures for veterinary medicinal products in the target markets.
- Monitoring of regulatory requirements and situation in the target markets and communication to RA leadership.
- Preparation and compilation of registration submissions in accordance with the legislation of the target market.
- Negotiate CMC aspects of applications and supplements to applications with the relevant Competent Authority and any other relevant regulatory agencies.
- Negotiate Clinical aspects of applications and supplements to applications with the relevant Competent Authority and any other relevant regulatory agencies.
- Prepare and submit any data sets required for effective and compliant promotion and ongoing maintenance of the products in the target markets.
- Archiving of registration documentation in global RA IT systems.
- Contribution to strategic plans for Target Market registration activities.
- Active cooperation with other RA team members and other Dechra departments (including PD) with regards to any needed local trials ensuring correct protocols followed including oversight if needed.
- Active cooperation with other RA team members and Dechra departments and participation in development and refinement of processes.
Ideal Candidate
Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly keen to hear from those who have/are:
- Active cooperation with other RA team members and Dechra departments and participation in development and refinement of processes
- At least 5 years of Pharmaceutical work experience
- Fluent in spoken and written English
- Computer literate with a working knowledge of Microsoft Office (including Word, Excel, and Outlook)
- High level of attention to detail and ability to follow detailed procedures and processes
- Effective listening, verbal and written communication skills
- Excellent interpersonal skills, with the ability to communicate effectively with all levels, establishing and maintaining effective working relationships
- Ability to plan, organise and prioritise workload to meet deadlines
- Professional approach to their work
- Ability to maintain a high level of confidentiality and discretion at all times
Required Qualifications:
- Minimum education level: B. Pharm or equivalent
- Current registration in good standing with the SA Pharmacy Council as a Pharmacist
- SA Drivers licence: Code B minimum
All applications received are reviewed by our internal talent acquisition team and we will get in touch if your skills and experience match what we’re looking for. Should you not hear back from us within 28 days please don’t be too disappointed – we may keep your CV on our database for any future vacancies which may be suitable and we encourage you to keep an eye on our careers site. For any questions or queries, please contact us at recruituk@dechra.com
Dechra Pharmaceuticals PLC