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Swedish Orphan Biovitrum AG

05.08.2022

Global Regulatory Lead (GRL)

  • Switzerland
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Swedish Orphan Biovitrum AG

Global Regulatory Lead (GRL)

Sobi offers the opportunity to work at an international pharmaceutical company focused on specialty pharmaceuticals meeting the high medical needs of rare disease patients and providing treatment and services to them. Our employees come from a variety of backgrounds within research, healthcare, industry and the academic sphere.

Global Regulatory Lead (GRL)

Role & Function

As a specialized biopharmaceutical company, we provide sustainable access to innovative therapies in the areas of hematology, oncology, immunology and specialty care. We bring something rare to rare diseases – a rare expertise and a strength in access that allows us to be a partner in care for those with high unmet needs. With offices in more than 30 countries and delivering treatments to patients in more than 70 countries we put our focus where we can have the greatest impact, in late-stage research and development, in patient access and commercialization. The hard work and dedication of our approximately 1,500 employees around the globe has been instrumental in our success across Europe, North America, Middle East and Asia, leading to total revenue of SEK 15.3 billion in 2020. Sobi's share (STO:SOBI) is listed on Nasdaq Stockholm.

Key Responsibilities

  • In order to support our business, the Global Regulatory Affairs (GRA) department is looking for aGlobal Regulatory Lead (GRL) Director, Oncology to join Sobi’s growth journey. Key Responsibilities and Accountabilities:Including, but not limited to the following
  • Single point of contact/single point of accountability within GRA on the Core Asset Team (CTA) and Medicines Development Team (MDT) for assigned program(s)
  • Chairs a Global Regulatory Team (GRT) of regulatory Subject Matter Expert(s)
  • Provides global regulatory leadership of assigned program(s)
  • Develops global regulatory strategies, including risk assessment and mitigation strategies. Champions use of expedited regulatory pathways globally to accelerate patients’ access
  • Attends major/critical regulatory Agency meetings (US FDA, EMA/CHMP, PMDA, NMPA/CDE) for assigned program(s)
  • May act as the European or US Regulatory Strategy lead (jointly with GRL role) depending on the complexity of the program and stage of development
  • May present to Senior Leadership regarding assigned program(s)
  • Cooperates with other departments and affiliates within Sobi, regulatory authorities, partners and regulatory consultants
  • Participates in strategic and regulatory evaluations of in-licensing matters. May have direct oversight of Regulatory Affairs team members supporting assigned program(s). Develops and coaches direct reports. Authority to approve services and costs within budget and delegation from Sobi authorized signatories. Review regulatory SOPs as needed

Qualifications

  • Degree in Life Sciences
  • Expert on all Regulatory Affairs processes, applications and regulatory environment to achieve and maintain marketing authorizations
  • Experience in Oncology, preferably malignant hematology, is required
  • Good knowledge of drug development and the rare diseases regulatory environment
  • Very good knowledge in written and oral English, knowledge of other languages is an upside but not required

Personal attributes

• Strong team-player with collaborative, respectful and flexible attitude and high engagement • Highly self-motivated and able to drive activities, solution-oriented personality• Excellent communication and negotiation skills In addition, you must demonstrate behaviors in line with Sobi's core values: Care, Ambition, Urgency, Ownership and Partnership.

Location

The position will be based in Basel, Switzerland.

Reporting to

Head of Global Regulatory Affairs

Recruitment contact & how to apply

Sobi is an affirmative action and equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, disability, age, sexual orientation, gender identity, or national origin. Sobi is committed to providing access, equal opportunity and reasonable accommodation for individuals with disabilities in employment, its services, programs and activities.

About Us

Sobi

www.sobi.com

Position

Global Regulatory Lead (GRL)

Function

Regulatory Affairs

Location

Switzerland

Closing date

1 Nov, 2022

Apply

Arbeitsort:

Switzerland

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