Do you have at least five years of experience with Regulatory Affairs and do you want to apply your knowledge and experience? Then we have an interesting temporary project for you!
As Associate Director Regulatory Affairs you make the RAM planning on an individual basis, to optimize the planning for the company (resources and department links within AP-MENA/SSA and with RAE). You are monitoring the implementation and follow-up of the agreed activities, and where required take action for correction or improvement.
You organize regular work-meetings with various disciplines in business and R&D departments, to ensure the required stream of information, and adequate strategic planning for budget, MTP and long term projects (global project planning) and you also organize regular work-meetings with various disciplines within AP-INTL, to ensure the required stream of information is incorporated.
You also lead, develop and manage the regulatory managers and you appraise staff and make development plans.
You support the Regulatory Affairs and Quality Director in overall quality improvement and assurance and management of the regulatory group.
You are responsible:
- For achieving the objectives as agreed in the planning;
- For timely reporting to the Regulatory Affairs and QualityDirector, if projects and timing might be or are jeopardized, and propose corrective action;
- To make proposals to the Regulatory Affairs and QualityDirector, related to development of procedures, SOPs, quality management tools, and databases;
- You continuous monitoring of activities and output of the RA group and making proposals to improve;
- You continuous updating the Regulatory Intelligence database.
You ensure (that):
- supplying the regulatory planning for their products on a regular basis to generate an affiliate planning and objectives;
- the approval of the (proposed) strategic objectives and planning by the Regulatory Affairs and Quality Director. Both for it short (1 yr) and mid term;
- an accurate and pro-active monthly reporting to the Regulatory Affairs and Quality Director;
- an update of all relevant databases within RAE and AP MENA/SSA;
- operational alignment of RA activities with other functional departments in AP-INT;
- an adequate planning and resources to adhere to the targets defined in the Business (Review) Meetings of AP-INT;
- a strategic and operational alignment of RA activities with other functional departments in AP-MENA/SSA and ensure adequate planning and resources to adhere to the targets defined in the Business (Review) Meetings of AP-INT;
- that RAMs in AP-MENA/SSA: be prepared(tailoring for local submission), be dispatch to agents and business partners, submission to local authorities and that there is maintained as directed by RAE and Marketing Authorization Applications (MAA);
- appropriate coaching and training.
It is a temporary project for six months.
To qualify for this position:
- You have at least 5-8 years experience with international regulatory affairs activities in the pharmaceutical industry;
- You have preferable additional team leader or project leader experience;
- You have experience with Regulatory in emerging markets or in the middle East / Africa;
- You have experience in working in multidisciplinary teams;
- You have academic qualifications preferably as a pharmacist, chemist or (medical) biologist;
- You have ability to work in a well organized project management, result oriented way also under pressure;
- You have excellent communication and writing skills (advise, convince, negotiate, listen, coach, present and edit);
- You have coaching skills and capability to lead an experts team, with experts working at various levels & experience;
- You have a relatively high abstraction level, to be able to switch to required levels and stand-points;
- You are ability to generate a realistic work-planning, derived from a vast number of data and information;
- You have good contactual skills (positive & constructive attitude, desire and ability to work in multidisciplinary / international teams);
- You have knowledge of the regulatory rules, guidance and institutes in MENA/SSA territory;
- You have adequate knowledge to work with information technology systems (e.g. Windows, MS Office and Dbases);
- You speak fluent English language, both spoken and written;
- You prefer to speak French / Arabic.
The company is one of the top 20 pharmaceutical companies in the world. As a young and forward-thinking company, she is dedicated to improving the lives of people around the world through the introduction of innovative and reliable pharmaceutical products.
For more information, please contact Geert-Jan Reijmer (Business Consultant) on +316 22 41 83 24.