Senior Regulatory Affairs Specialist

Perrigo Senior Professional Regulatory Affairs - Lifecycle Management - - Medicines Location: Allegan, MI, US, 49010 Morristown, NJ, US, 07960 Description Overview We are excited to recruit a Senior Professional within the Medicines classification team for Lifecycle Management, you will play a key role in delivering Perrigo's regulatory strategy across the product lifecycle. You will support the development and execution of regulatory strategies, ensuring the consistent delivery of high-quality regulatory outcomes across a diverse and complex portfolio. You will be responsible for managing lifecycle management activities, overseeing the preparation, submission, and maintenance of approved applications and regulatory dossiers in line with FDA requirements, relevant ICH expectations, other applicable health authority requirements, and business priorities. You will proactively identify risks, support mitigation planning, and ensure timely, compliant submissions that help maintain supply continuity, consumer safety, and market access. You will provide clear direction, support capability development, and foster a culture of accountability and continuous improvement. You will manage priorities across multiple activities, ensuring effective execution and alignment with departmental and organisational goals. Working closely with cross-functional stakeholders—including Quality, Safety, Supply Chain, and R&D—you will contribute regulatory expertise to change management and business initiatives. You will help translate regulatory requirements into practical, actionable plans that support product maintenance, compliance, and portfolio optimisation. You will also contribute to the continuous improvement of Regulatory Affairs processes and ways of working, helping to drive efficiency, consistency, and scalability across lifecycle activities. Through your role, you will support Perrigo's ability to meet evolving regulatory requirements while maintaining high standards of compliance and quality. This role offers the opportunity to make a meaningful impact within the Regulatory Affairs organisation—supporting product availability and regulatory performance while developing your leadership and technical expertise in a dynamic, global environment. Scope of the Role Leads complex, high-impact lifecycle regulatory projects and workstreams across multiple drug products, the US market and/or global markets, or regulatory pathways. Provides strategic regulatory leadership for significant post-approval supplements and annual reportable changes, remediation, and compliance risks, ensuring lifecycle delivery protects compliance posture, approved application commitments, and supply continuity. Acts as a recognised subject matter expert, mentors others, and drives governance and continuous improvement within the LCM team. Leads complex change programmes such as site transfers, CMC and quality-related post-approval changes, renewals, remediation, or other high-risk lifecycle activities for NDA, ANDA, OTC monograph, and/or related drug product portfolios. Operates with high autonomy and is accountable for recommendations and technical direction on complex topics within delegated authority. Acts as senior individual contributor and mentor, leading cross-functional governance with impact across multiple products or portfolio workstreams. Strategic Lifecycle Leadership Lead assessment and management of complex and high-risk post-approval changes across the US market and/or global markets, defining data needs, appropriate FDA reporting category, submission strategy, and dossier updates. Provide strategic oversight of lifecycle dossiers, technical documentation, and inspection readiness; set and coach high standards for right-first-time quality. Lead complex lifecycle submissions across products and markets, including post-approval supplements, annual reportable changes, renewals, remediation, escalated RFIs, and deficiency responses. Approve or recommend change approach, appropriate FDA reporting category, and submission strategy within delegated remit, and elevate major compliance or supply risks through governance. Risk, Governance & Compliance Anticipate and mitigate significant regulatory risks and lead issue resolution for compliance gaps or supply disruption threats. Lead cross-functional risk reviews, remediation planning, and governance forums with Quality, Supply, Safety, R&D, Manufacturing, RegOps, and Cluster RA. Drive cross-functional improvements to lifecycle processes and systems, define implementation steps, and embed standard work. Leadership & Influence Act as regulatory lead for complex health authority interactions, including FDA as applicable, and coordinate consistent evidence-based responses. Coach and quality review the work of D2/D3 colleagues and embed Good Documentation Practice within the team. Influence senior stakeholders and cross-functional teams without formal authority to achieve aligned decisions and timely delivery. Experience Required Typically 58+ years in Regulatory Affairs with proven experience leading complex regulatory projects and authority interactions; relevant scientific or technical degree preferred. Sustained performance in complex lifecycle roles or similar experience considered. Demonstrated capability in strategic lifecycle thinking, governance, and coaching others. Nearest Major Market: Grand Rapids Equal Employment Opportunity/M/F/disability/protected veteran status. PI286170084 #J-18808-Ljbffr