Director RA, Life Cycle Management

Director RA, Life Cycle Management

Orifarm

Do you want to ensure and maintain a high quality of the dossiers for Orifarm’s active products? – Come join a company with a strong presence in the Nordic generic markets.

Orifarm’s regulatory organisation is growing, and this is your chance to play a key role in building the future foundation for the growth as Director RA, Life Cycle Management. This entails the responsibility to secure RA LCM compliance upon order, launch and release including a good and positive collaboration between stakeholders internally and externally while utilizing and developing your people management skills.

As Director RA, Life Cycle Management, you will have direct report to the VP of RA Healthcare, and you will lead an organisation consisting of 3 Teams whose foremost purpose and responsibility are to maintain a high quality of the dossiers for Orifarm’s active products

The Life Cycle Management department is responsible for keeping up to date with legislation and guidelines, updating dossiers accordingly and for the submission of variations to the authorities. They have a close collaboration with manufacturing sites/suppliers, QA and Supply Chain. Moreover, they update products to reduce costs, add new strengths, pack sizes and indications to increase income and add additional suppliers of raw materials to reduce risk of stock-out situations.

Management

  • Daily Management of Team Managers, including employee development, interviews, plan for courses/training, staff requirements and resource planning, hiring/dismissals.
  • Secure continuous development of the RA LCM management team.
  • Coordination and prioritization of task in RA LCM management team and across RA Healthcare.
  • Secure well-being, development, results, and efficiency (KPI’s) in RA LCM and RA Healthcare in general.
  • Support to rolling forecast for RA Healthcare-department.
  • Secure resources on an overall level within the department.

Strategy

  • Responsible for compliance with regulatory legislation and guidelines in RA LCM.
  • Secure resources for new initiatives/challenges in legislation.
  • Responsible for SOPs within RA LCM in close collaboration with RA Healthcare Management team.
  • Secure development of clear processes within RA LCM and towards internal stakeholders.
  • Strategic development of RA LCM in close collaboration with RA Healthcare overall strategy, with focus on LCM and launch.
  • Resource optimization: Coordination of tasks, secure resources for new initiatives, advise, projects and superuser roles.
  • Secure training and knowledge maintenance of the employees.
  • Secure cross functional collaboration to stakeholders.
  • Secure agile workflow and targets are reached across RA.

Experience and qualifications

  • Solid experience within RA for both operations and life cycle management phases in pharmaceuticals.
  • Strong knowledge of the global regulatory framework
  • People management experience
  • Excellent strategic thinking

About

Orifarm was founded in Denmark in 1994 and Orifarm Group is today the largest supplier of parallel imported pharmaceuticals in Europe and have a strong presence on the Nordic generic markets. Orifarm supplies a wide range of high-quality pharmaceuticals across several therapeutic areas and stages of illness. Orifarm’s portfolio covers pharmaceuticals for primary as well as secondary care by specialists, over the counter (OTC), and consumer healthcare products. Orifarm has become an international company and operate in Denmark, Czech Republic, Germany, Sweden, Norway, Finland, the Netherlands, Austria, the UK, Poland, Belgium, the Baltic States, and the USA. The entire group employs close to 2,200 people and continue to add new employees to support them in their growth.

Moreover, with the acquisition of a portfolio of OTC and prescription pharmaceuticals from Takeda Pharmaceutical in 2020, Orifarm has further underlined their presence as a fast growing generic and OTC company in Northern Europe.

Contact and application

The recruitment process is carried out in collaboration with the consulting company Compass Human Resources Group. If you want to learn more about this position before submitting your application, please do not hesitate to contact Consultant Alexander Lüger Krøijer or Research Consultant Signe Bülow Hansen on +45 70 20 12 75. Please submit your application and CV as soon as possible, if you are interested. Applications will be processed on an ongoing basis. Please note that all enquiries will be handled with confidentiality and that we will reply to the email address from which you send your CV.

Deadline: As soon as possible
Workplace: Søborg or Odense
Reference: 2225348 
Company: Orifarm A/S