Sr Regulatory Affairs Manager

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Municipality
Leiden
Education
HBO
Hours per week
40 hours
Contract type
Tijdelijk met uitzicht op vast
Salary indication
€7500-10000
Vacancy number
#1AV0022254

About the job

About the job

Purpose of the full time position:

  • 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
Strategic alignment

  • 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.

Quality management

  • 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

Team management
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:
     Covering letter
     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

  • You can start immediately for a fulltime job (40 hours);
  • One project for 6 months (31-12-2020)
  • Excellent salary (7500 - 10.000)

Job requirements

Experience:

  • 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)

Other requirements:

  • You live in the Netherlands

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).

Job information

Unique Uitzendbureau Leiden

Schipholweg 55
2316 ZL Leiden

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