Global Regulatory Affairs Labeling Lead - REMOTE OKAY
5+ years of experience in Regulatory Labeling in CCDS, USPI and SmPC a MUST
- In support of these activities, the Provider will adhere to Client established timelines as indicated in SOPs, implementation guidelines, job aids, guidance documents, regulatory requirements, training materials and other related communications provided by Client.
- Reinforce labeling strategy by guiding and advising the Labeling Team on internal labeling guidance and policies and will raise awareness of important factors to consider when revising the label.
- Remain up-to-date with labeling guidelines and regulations as they pertain to the development/maintenance of US and EU labeling and advise the Labeling Team on the application of these labeling principles.
- Be knowledgeable on key labeling requirements worldwide.
- Ensure that downstream impact on CLDs is considered during Labeling Team discussions.
- Advise the Labeling Team on the content of other labels in the same therapeutic class, including competitor labeling, to help guide the team in developing labeling text.
- Provide project management to the Labeling Team throughout the entire process, from the request to update a CDS/USPI/SPC through notification to stakeholders, in order to ensure that these documents are produced in a timely manner according to internal SOPs and external regulatory requirements. This includes setting clear targets and prioritization plans, ensuring that Labeling Teams are aware of the required timelines and following up with Labeling Team members throughout the process so that deliverables remain on target to meet internal and external deadlines.
- Serve as the GLM primary point of contact for Labeling Teams (e.g., Regulatory Strategist, Safety Risk Lead, Functional Line SMEs, Labeling Justification Document/Clinical Overview author) and provide day-to-day direction to Labeling Operations Specialists so that labeling can be prepared and managed appropriately throughout Client processes and systems.
Interface with Hub Labeling Managers and PCO colleagues to support timely and quality submissions globally.
- Support the use and development of current and new tools, technologies and processes to support efficient global label development and worldwide submissions and approvals.
- Utilize regulatory, labeling and project management expertise to oversee and support the development, review and delivery of CDS, USPI, SPC (for products registered in the EU via the Centralized, Mutual Recognition or Decentralized procedures) and their associated Patient Labeling Documents.
- Manage complex labeling projects (e.g., development labeling for NCEs and NMEs) with some oversight.
- Engage in and contribute to Labeling Team discussions around content and format of the above mentioned documents, as well as downstream impact on CLDs worldwide.
- Act as a reviewer and approver during review of labeling ensuring that content complies with regulatory requirements and guidelines and company policies and procedures and that the label content can be incorporated into CLDs worldwide.
- Prioritize Labeling Team activities and set clear targets using effective project management.
Follow up with Labeling Team members to secure their contributions so that internal and external deadlines are met.
- Identify and assist teams to overcome barriers in achieving quality and compliance.
- Ensure all actions taken within role follow applicable SOPs and associated documents so that high quality delivery of outputs and compliance is maintained.
- Ensure appropriate tracking of labeling projects via defined procedures and optimal use of systems.
- Contribute to the development of continuous improvement of business practices associated with processes and tools.
- Advocate for new labeling initiatives to immediate labeling stakeholders (e.g., Labeling Teams).
- For deliverables in scope, support responses to inquiries from Client colleagues related to inspection activities and regulatory agency questions.
- Member of teams tasked with development of continuous improvement of business practices associated with processes and tools.
- Advocate for new labeling initiatives to labeling stakeholders within Therapeutic Area or Business Unit.
- Mentor other GLLs as needed.
- Knowledge of U.S. and EU regulations and guidelines pertaining to labeling and demonstrated ability to decipher and understand implications of label changes on pending and approved labels.
- Demonstrated knowledge and understanding of company Core Data Sheets and the dynamics of Labeling Team purpose and objectives.
- Demonstrated ability to understand how updating one section of a label may impact another and to propose recommendations to the Labeling Team.
- Clear and effective written and verbal communication skills. Ability to liaise with stakeholders using effective means of communication. Demonstrated ability to influence and negotiate where necessary, across a highly matrixed team.
- Ability to work well in cross-functional teams, exhibiting a combination of active listening skills and the confidence to guide decision-making for the document content strategy.
- Ability to interact effectively with all levels/roles of project team members.
- Ability to manage own time for all projects, and work on many tasks in parallel.
- Takes ownership and accountability for assigned projects.
- Proven ability to effectively lead project team members in order to resolve issues.
- Consistent ability to foster strong matrix team working relationships. Proven track record of facilitating groups of individuals to work together on creating solutions.
- Proven ability to make sound decisions. In doing so, the Provider staff will proactively seek information and insight from a broad range of sources and weight benefits and risks before making important decisions.
- Interfaces directly with senior management as appropriate on prescribing information content and requirements.
- Independently seeks to resolve problems in a proactive manner.
- Proven understanding of the dynamics and purpose of company Core Data Sheets (CDS); experience in reviewing and understanding of implications of the CDS.
- Possesses advanced knowledge of external labeling guidelines and regulations and internal labeling policies and procedures.
- Proven ability to successfully understand regulatory implications of product strategy with regards to the product label, assessment and practical management of associated impacts.
- Demonstrated ability to interpret and apply global and local regulatory guidance around labeling and associated supportive documentation, both in the pre-approval and post approval (maintenance) stages.
- Demonstrated ability to develop strong and positive working relationships across multiple cultures and within global environment.
- Knowledge of global/regional regulatory guidelines and requirements important.
- Excellent written and verbal communication skills essential.
- Complete fluency in English Language.
- Proven strength in logical, analytical and writing ability essential.
- Strong project management skills and attention to detail required.
- Proven ability to negotiate, influence and problem solve.
Please call Lindsey Summers with questions at 303-694-5482
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Ascent Life Sciences specializes in Medical Device, Pharmaceutical, Biotech, and clinical validation search for contract staffing, contract-to-hire, direct hire search and small project consulting services for FDA-regulated industries