Sr. Director, - Regulatory Affairs

Job Description

Reporting to the Executive Director, RIIM, this role will be accountable to ensure a holistic Regulatory centric Data Management (RDM) capability and related data centric submissions within GRACS, are implemented and maintained. This role has broad accountabilities for the following:

• Regulatory Data Management (RDM) Strategy & Regulatory Data Standards Governance

• Regulatory Compliance and Risk Management for Regulatory Data

• Direct and Indirect(e.g., partnering with CMC, Labeling, etc) execution activities that support Data-based Submissions (e.g. XEVMPD, IDMP, PQCMC, SPLetc.)

• Internal & External Stakeholder Engagement and Change Management for Regulatory Data Standards

The complexity of gathering, organizing, and validating structured data is critical for GRACS and other critical stakeholder areas including PV, Clinical and Supply Chain to ensure that datasets are complete and consistent.Having a robust Regulatory data management capability is criticalto maximise connectivity and data flows across our multiple Veeva Vaults.

This role will enable futureproofing of regulatory submissions and ensuring compliance with evolving standards beyond 2025 (i.e. IDMP related activities and submissions to Global Health Authorities). This will result in positioning the Company competitively by streamlining product lifecycle management and helping to accelerate time-to-market.This will also enable building stronger relationships with regulatory authorities through improved transparency and communication.

Whilst leading a direct and matrixed team of employees, contractors and vendors, the role is also responsible for collaborating effectively with otherkey stakeholders to drive the strategic direction of the RDM capabilities and data centric submissions. The ability to influence and negotiate with key cross functional Leaders is critical. TheSenior Director should have strong managerial experience, a high-levelstrategic understanding of regulatory data governance and master data management principles, dataflows andactivities that occur at global and regional level as well as the requisite capabilities that enable execution of time sensitive strategies.

This role has considerable responsibilities as it relates to internal and external stakeholder management. Internally, it is critical to define and convince key stakeholders of the value and criticality of the need for Master Data Management at an enterprise level. This includes fostering a culture of data stewardship and ensuring stakeholder engagement throughout the organization. This involves promoting the importance of data governance and aligning goals across different departments. Externally, this role will be a leader in advocating with trade, consortia and as appropriate with Health Authorities to promote harmonization and adoption of global standards around regulatory data management practices to promote interoperability and efficiencies to benefit both HAs and industry constituents.

Primary Activities include but are not limited to:

• Data Centric Submissions: Lead the data submissions team that is accountable for the on-time, accurate and compliant submission of XEVMPD deliverables in the EMA region with responsibility of meeting the reporting deadlines and quality measures specified in local SOPs

• Data Centric Business System Owner Operations: Lead the regulatory data governance and standards team, which manages regulatory data governance and mediation, ownership, and stewardship roles, including business system operations.

• Veeva ARC: Playing a lead role in the Veeva ARC implementation and ongoing capabilities that support effective regulatory data management practices - ensuring to the widest extent possible interoperability for cross functional decision making and configuration choices.

• Develop a framework for understanding and managing regulatory requirements related to data governance and RDM. This involves keeping up on changes in regulations across different markets and ensuring that data practices comply with them. Accountable for maintaining a framework for regulatory control vocabularies (e.g. SPOR)

• Focuson broader data governance rules and mediation in and collaborate closely with other divisional, enterprise and functional data centric teams in the business and IT

• Define the development of Global IDMP Data strategy within GRACS. Work with key stakeholders to implement the strategy andintegrate the needs and requirements from Cross functional partners ensuring that the right data is captured and structured in a way that aligns with ISO IDMP’s guidelinesand is enriched andmaintained (e.g. eAF and EMA PMS)

• Represent the Company in international trade association committees and meeting groups associated with Regulatory Data, IDMP and associated regulatory IT/telematics topics (for example EFPIA, PhRMA and ICH groups).As the opportunity arises, take on leadership roles within the trade association committees and represent the industry in meetings and negotiations with health authorities and other stakeholders.

Education:

• B.S. with 15+ years of industry experience, at least 6 of those in a regulated environment

Required:

• Experience in developing strategies to establish master data management and governance structures in a regulated business environment

• Knowledge of key regulatory data that is tracked and managed within regulatory, clinical & pharmacovigilance processes

• Demonstrated ability to collaborate with senior management and information workers on the importance and need for master data managementIgovernance

• Experience in working within relevant Industry Trade Associations/Health Authorities with the ability to influence topics/outcomes in the best interest of the Company

• Strong knowledge of regulatory information assets

• Business system operations accountability experience

• Experience in understanding complex regulatory information relationships

• Broad organizational awareness; can work across multiple levels within an organization

• Project management skills

• Excellent communication skills

• Able to operate effectively in ambiguity

• Strong business acumen

Current Employees apply HERE

Current Contingent Workers apply HERE

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Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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Expected US salary range:

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listedhere.

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Employee Status:

Regular

Relocation: