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Kailera Therapeutics · 3 weeks ago

Director, Global Regulatory Affairs (Submission Project Management)

Waltham, Massachusetts

Full-time

Hybrid

Director/Executive

$175K/yr - $230K/yr

10+ years exp

Kailera is committed to developing therapies that empower individuals to transform their lives and improve their health. The Director of Global Regulatory Affairs will lead cross-functional teams in the planning and execution of compliant marketing authorization filings to support product approvals and organizational growth.

BiotechnologyPharmaceuticalTherapeutics

Responsibilities

Contribute to and lead the execution of submission strategies in alignment with corporate objectives and regulatory requirements

Provide guidance on evolving global regulatory landscapes, including guidelines, regulations, and other factors related to regulatory filings

Lead and manage cross-functional submission team meetings and workstreams (Regulatory, Clinical, Quality, CMC, Medical Writing)

Oversee project team delivery of the marketing authorization applications

Liaising with regulatory operations department to ensure all components are identified on the submission content plans and submissions meet technical, formatting, and compliance standards

Develop and manage marketing authorization project timelines and deliverables

Identify risks and manage operational risks, implementing mitigation/contingency strategies to ensure submission success

Track progress and report status updates to executive leadership

Establish best practices and SOPs as needed for marketing application related submission processes

Ensure adherence to ICH, FDA, EMA, and other global regulatory regulations/guidelines

Build strong collaborative relationships across departments

Qualification

Regulatory AffairsGlobal SubmissionsProject ManagementRisk AssessmentIntegrated Drug DevelopmentPMP CertificationInfluence SkillsCommunication SkillsOrganizational SkillsLeadership AbilitiesNegotiation Skills