Director, Global Regulatory Labeling
Vor 3 Tagen
**The Role**:
Moderna Therapeutics is seeking a Director of Regulatory Labeling to support new and existing programs to be based in Basel or other International Moderna hub. This is a newly created role intended for a forward looking, creative regulatory professional able to anticipate and address the challenges involved in swiftly delivering labeling for products to new markets, especially in EU/UK and other major markets such as Switzerland and Australia.
The Director will be a strategic leader within Regulatory Affairs, responsible for developing and executing regulatory labeling, especially generation of new prescribing information and changes to existing labeling, and submission of labeling information to Health Agencies.
**Here’s What You’ll Do**:
Develop and maintain current knowledge of labeling regulations and industry standards for labeling and communicate requirements to stakeholders as needed.
Direct the labeling control process for tracking, implementation, and regulatory submission of changes to new and existing labeling for EU/UK/Major Markets for all of Moderna’s commercial products as well as those in late-stage development.
Develops labeling content, format and accountability for regulatory submissions (MAAs) and related supplements and amendments. Ensure that new labeling text meets regulatory labeling requirements.
Develops content for artwork related to MAAs and related supplements and amendments. Ensures that new labeling text meets regulatory labeling requirements. Works with cross-functional team and provides input on new trade names, established names, graphics and logos.
Interface with Project Teams to ensure consistency of labeling processes and local compliance with CCDS.
Direct submission of labeling materials and supporting documentation to regulatory agencies in accordance with submission requirements.
Serve as a Labeling expert in Regulatory Affairs sub teams for activities related to the development of labeling for regulatory submissions.
Assist with gathering of information for labeling-related change controls and processing of these details within the electronic document management system.
Effectively communicate the regulatory labeling strategy, risks, mitigations and overall plans to the Regulatory Affairs Management Team, Project Development Team and senior management, as relevant.
Partner with the Global Regulatory Lead to develop Target Label Profiles to support all phases of clinical development.
Provide input to the end-to-end labeling process.
Liaise within pharmaceutical/biotech industry to maintain knowledge of evolving/emerging industry standards and trends; and influences the industry environment regarding medical writing and labeling.
May be responsible for line management and development of direct reports in the future.
**Here’s What You’ll Bring to the Table**:
BA/BS degree in a scientific discipline required, Masters or PhD preferred.
10+ years of experience in the pharmaceutical industry, preferably in Europe.
7+ years of experience in Regulatory labeling, preferably working closely with EU labeling. Strong knowledge of artwork development, review and approval required.
Strong knowledge of current global regulations, including specifically: e.g. vaccine development regulations and registrations pathways.
Strong experience with CTD format and content regulatory filings
Exceptional written and oral communication
Experience dealing with broad range of stakeholders at all levels internal and external to the company
Experience facilitating meetings and driving consensus and results.
Excellent leadership, communication (verbal and writing) and collaboration skills.
Proven ability in medical/technical writing.
Labeling experience (CCDS, US, EU, UK, other major markets) in infectious diseases or vaccines or other relevant industry experience related to developing regulatory documentation is desirable.
Innate sense of urgency in regards to EMA/MHRA/Other HA communications and response timelines to provide coverage for product approvals and labeling negotiations.
**Integrity**: overriding commitment to integrity and high standards in self and others.
**Achievement or Result Orientation**: a concern for working well or for surpassing a standard of excellence.
**Strategic orientation**: ability to link visions and daily work
**Communication**: ability and intend to effectively explain, describe or convey information to a variety of audiences. Specifically, interacts effectively as member of the Regulatory sub-team, communicates effectively strategies to the Global Labeling Committee and collaborates with business partners, including affiliates and third parties.
**Develops others**: involved in a genuine intent to foster development of others; mentoring
**Flexibility/adaptability**: ability to adapt to, and work effectively within a variety of situations and with various individuals or groups.
**Relationship building, teamwor
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