Regulatory Affairs TA and International Team Lead - Geneva

Location: Switzerland - Meyrin/Geneva

Function: Regulatory Affairs

Company: OM Pharma

Marilda Martins

International Talent Acquisition Specialist

+41 58 851 67 69

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About You

We are currently looking for an experienced Regulatory Affairs TA and International Team Lead who leads key activities of the TA and International team. You are responsible for the definition and implementation of regulatory strategies based on the good knowledge and appropriate interpretation of guidelines and directives. Based in Geneva, you report to the Head of Regulatory Affairs OM Pharma and your responsibilities include:

  • Lead the TA and International team (5 direct reports and up to 8 team members)
  • Contribute to the definition and the implementation of regulatory strategies to support/maintain registrations and coordinate operational activities of the team
  • Coordinate life cycle activities / maintenance of existing prodiuct licenses
  • Coordinate dossiers submission accodinng to the defined timelines (renewals, variations, responses to HA questions
  • Ensure compliance of the portfolio with legal requirements
  • Conduct risk assessments and set-up mitigation plans
  • Cooperate with internal stakeholders (marketing, Commercial, Global Drug Safety…) to ensure alignment on strategies
  • Be responsible for the management and development of staff by overseeing recruitment and training, evaluating performance, defining and assigning responsibilities, providing opportunities for career development
We are looking for a customer- and service-oriented person who brings experience in working with a wide variety of stakeholders across diverse teams both internally and with external partner companies. Furthermore, your profile meets the following criteria:
  • Degree in Life Sciences, Pharmaceutical Sciences or Medical
  • 8 to 10 years of experience in Regulatory Affairs
  • Ability to perform comprehensive gap assessments and build effective regulatory strategies (Good knowledge and appropriate interpretation of guidelines, directives etc…)
  • Self-assertion, creative and solution-oriented work approach
  • Accuracy, flexibility, open minded, team spirit, organised, autonomous
  • Strategic thinking and acting, entrepreneurship skills
  • Experience in people management and development
  • Excellent communication and negotiation skills at all levels, diplomacy and respectful behavior
  • Discretion in the handling of confidential information
  • Good command of French and English both in written and oral conversation 

You are a mature regulatory professional and describe yourself as a solution oriented and flexible person able to influence internal and external stakeholders. Your work is characterized by its accuracy, a proactive approach and by the ability to work under stress and to deal with tight deadlines. These skills will ensure your success in this role.

About Us

OM Pharma, integrated in Vifor Pharma and a company of the Galenica Group, is a biotech firm specialised in products for infectious diseases/OTX. Vifor Pharma is a world leader in the discovery, development, manufacturing and marketing of pharmaceutical products for the treatment of iron deficiency. Additionally, the company offers a diversified portfolio of prescription medicines as well as over-the-counter (OTC) products. Headquartered in Zurich, Switzerland, Vifor Pharma has an increasingly global presence and a broad network of affiliates and partners around the world.

For more information about Vifor Pharma and its parent company Galenica, please visit www.viforpharma.com and www.galenica.com.

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