To ensure 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.
To ensure that RAMs in AP-MENA/SSA:
prepare (tailoring for local submission),
dispatch to agents and business partners,
ensure submission to local authorities and
maintain as directed by RAE,
Marketing Authorization Applications (MAA) according to current legislation, in order to obtain and maintain marketing authorizations in the geographical business area of AP MENA/SSA. This is directly linked to the strategic business obligations of the affiliate to the European objective.
To support the Regulatory Affairs and Quality Director in overall quality improvement and assurance and management of the regulatory group.
The Manager will also have specific dossier/regional and/or product responsibilities and tasks (RAM responsibility).
Core Tasks, Responsibilities & Authorities
1. Management responsibility
To 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).
To organize regular work-meetings with various disciplines within AP-INTL, to ensure the required stream of information is incorporated
To ensure operational alignment of RA activities with other functional departments in AP-INT
To ensure adequate planning and resources to adhere to the targets defined in the Business (Review) Meetings of AP-INT.
Co-ordination and reporting
To ensure that RAM’s are supplying the regulatory planning for their products on a regular basis to generate an affiliate planning and objectives.
To challenge 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).
To secure approval of the (proposed) strategic objectives and planning by the Regulatory Affairs and Quality Director. Both short (1 yr) and mid term.
To monitor the implementation and follow-up of the agreed activities, and where required take action for correction or improvement.
Responsible for achieving the objectives as agreed in the planning.
To secure an accurate and pro-active monthly reporting to the Regulatory Affairs and Quality Director.
To secure updating of all relevant databases within RAE and AP MENA/SSA.
Responsible for timely reporting to the Regulatory Affairs and QualityDirector, if projects and timing might be or are jeopardized, and propose corrective action.
Responsible to make proposals to the Regulatory Affairs and QualityDirector, related to development of procedures, SOPs, quality management tools, and databases.
Continuous monitoring of activities and output of the RA group and making proposals to improve
Continuous updating of the Regulatory Intelligence database
Functional, operational and hierarchical management of regulatory team.
Lead, develop and manage the regulatory managers.
Ensure appropriate coaching and training.
Appraise staff and make development plans.
2. RAM responsibility
Prepare a MAA file (or other type of regulatory submissions)
Identify requirements, prepare a planning and coordinate preparation of the submission in cooperation with relevant peers within RAE department of APERD
Provide instructions to other departments (team members) about technical requirements of documents to be integrated in MAA (or other submissions e.g. variations, renewals, PSURs)
Review all relevant data and documents from the different departments and/or third parties involved for eligibility (contents) and consistency throughout the MAA (or other type of regulatory submission)
Collect necessary data, documents and samples (active substance, impurities, finished product) to be included in the MAA (or other type of regulatory submission)
Write or contribute to the following parts of the MAA file:
Administrative data (Application form + appendices)
SPC (Summary of Product Characteristics)
Patient Information Leaflet and Labelling
Compose MAA file (or other type of regulatory submission)
Compile MAA file and check for completeness, correct sequence, correct version of documents
Prepare table of contents
Submit / Coordinate submission MAA file (or other type of regulatory submission)
Distribute MAA file to Regulatory colleagues of agents/business partners
Assist regulatory colleagues of agents with proper and timely submission to relevant regulatory authorities
Defend / Coordinate defence MAA file (or other type of regulatory submission)
What we offer
What we offer
You can start immediately for a fulltime job (40 hours);
One project for 6 months (31-12-2020)
Excellent salary (7500 - 10.000)
At least 5-8 years experience with international regulatory affairs activities in the pharmaceutical industry
Preferable additional team leader or project leader experience
Experience in working in multidisciplinary teams
Training / competencies:
Academic qualifications preferably as a pharmacist, chemist or (medical) biologist
Ability to work in a well organized project management, result oriented way also under pressure
Excellent communication and writing skills (advise, convince, negotiate, listen, coach, present and edit)
Coaching skills and capability to lead an experts team, with experts working at various levels & experience
Relatively high abstraction level, to be able to switch to required levels and stand-points
Ability to generate a realistic work-planning, derived from a vast number of data and information
Good contactual skills (positive & constructive attitude, desire and ability to work in multidisciplinary / international teams)
Good knowledge of the regulatory rules, guidance and institutes in MENA/SSA territory
Adequate knowledge to work with information technology systems (e.g. Windows, MS Office and Dbases)
Fluent in English language, both spoken and written
Specific physical/mental demands:
Dealing with diverse cultural settings
Dealing with diverse characters (staff central/ local)
You live in the Netherlands
About the company
About the company
Be ‘On the Forefront of Healthcare Change to turn innovative science into value for patients’ is their long term corporate vision for continued success. In order to realize this, they must constantly challenge themselves, be open to change and work together. It is an innovative and successful organization because of diverse and talented people who respect each other and who value the power of long-term relationships. They believe that it is important to create a positive working environment and to inspire employees to develop their talents. They want their employees to achieve full professional potential as they engage closely with the company, furthering its success and growth, and reinforcing its contribution to society.
It is a Japanese multinational pharmaceutical company employing over 17,200 people worldwide with global sales exceeding 10 billion euro. The company stands on the forefront of healthcare change, turning innovative science into value for patients. By repeating this cycle continuously, they are pursuing the sustainable growth of corporate value. With over 4,700 employees, the EMEA-region (Europe, Middle East and Africa) is an important and growing region.
The company is based in Leiden. It's easy to reach with the car and they have free parking. Also you can go with the public transport from Leiden, Den Haag, Rotterdam and Amsterdam (Schiphol).