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Company

Sobi - Swedish Orphan Biovitrum AB (publ) · 1 day ago

Head of Global Labeling Strategy

Waltham, MA

Full-time

Remote

Director/Executive

10+ years exp

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BiotechnologyGenetics

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Responsibilities

Provide oversight of product labeling at Sobi

Promotes partnerships with project/program teams to ensure key submission milestones are met

Sets functional goals which contribute to the departments vision and long-range planning

Leads a team of Global Labeling leads and Labeling Co-ordinator

Provides line management to direct reports including training, performance management, professional development and coaching

Provides excellent understanding of labeling requirements and guidance

Manages Sobi Executive Labeling Committee (ELC) and is responsible for follow-up on ELC decisions regarding labeling

Ensures that product labeling reflects a complete and accurate description of the risks and benefits of Sobi products based on available data

Ensures timely creation and updates of CDS that represent Sobi’s position on maximum efficacy and core safety of Sobi’s products and approval of CDS deviations

Provides oversight of labeling operations work including artwork and mock-up creation and updates

Makes decisions on administrative and operational matters and ensures the labeling team effectively achieves its objectives

Utilize strategic thinking and risk assessment capabilities in your area of responsibility

Maintain knowledge of global competitive landscape, regulatory environment, regulations, and best practices

Contribute to the development and maintenance of Regulatory Affairs working practices & procedures

Additional duties may be assigned, as needed

Qualification

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Life Sciences DegreeRegulatory Affairs ExperienceLabeling Regulations KnowledgeINDNDA ProcessesProject ManagementCross-functional Team LeadershipMS-Office Proficiency

Required

A University Degree in Life Sciences is required

10 years of industry experience of which at least 8 years of experience within Regulatory Affairs in a Labeling role

At least 5 years of formal people management

Diverse experience working with a variety of pharmaceutical products

Extensive experience working with regulatory labeling for Prescription medicines and interacting with Regulatory Agencies including the US FDA on labeling issues

Experience leading and managing updates to prescribing information

Extensive experience working in a global environment

Experience of leading projects and cross-functional teams

Extensive knowledge of Labeling regulations and guidance

Thorough knowledge of the drug development process, with a focus on IND and NDA processes

Above-average proficiency with basic technology tools (e.g. MS-Office, etc.)

Demonstrate excellent communication skills (oral/written/listening) in English

Results driven and team-oriented attitude with the ability to influence outcomes

Excellent organizational and time management skills to effectively manage multiple ongoing projects simultaneously

Proven ability to innovate, especially with analysing & solving problems, with minimal supervision and exceptionally keen skills for attention to detail

Proven success in simultaneously handling strategic and transactional responsibilities, especially in a small-team environment