CSL

Manager, Regional Regulatory Lead – LCM

CSL

full-time

Posted on:

Location Type: Hybrid

Location: King of Prussia • Massachusetts, Pennsylvania • 🇺🇸 United States

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Job Level

Senior

About the role

  • With support, accountable for assigned product relationship with a health authority (FDA or EMA), ensuring alignment with product GRL and as needed, support from Head, Regulatory TA if escalation is required.
  • May negotiate on behalf of CSL with health authority to achieve desired regulatory outcome.
  • Developing regional knowledge regarding health authority requirements, regulatory filing pathway/categories, processes, and ways of working and thus, can provide relevant guidance / assessment to internal stakeholders (e.g., GRAST, GRL & Commercial) on means to address project challenges, leverage regulatory opportunities and advise on risk for developmental, new, and marketed products.
  • Under the product GRL, supports regional regulatory activities as assigned, inclusive of potential to contribute to core document preparation (e.g., core briefing book, pediatric plans, etc.), product filing preparation activities (investigational, new, and marketed) and health authority engagements.
  • Responsible for Module 1 documentation required for submission and supports response to health authority comments activities with guidance from GRL.
  • Actively contribute to the GRAST activities, strategy development, document reviews and competitive regulatory intelligence.
  • Ensures on-time execution of regulatory activities at the regional level, achieving positive regulatory outcomes.
  • Partners with GRL to develop internal communications and distributes GRAS communications to regional commercial stakeholders.
  • Actively connects and maintains relationships with GRAST members, including GRAS Regions and Regulatory CMC.
  • Proactively fosters and promotes effective relationships across Global Regulatory Strategy.
  • Updates and maintains applicable regulatory systems (e.g., Veeva) to ensure tracking and compliance deliverables.
  • Applies the CSL Leadership Capabilities – Build Bridges, Think Beyond, Unleash Outcomes, Ignite Agility, Inspire the Future and Cultivate Talent – to oneself.

Requirements

  • Bachelor’s degree (four-year university degree) in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science is required.
  • An advanced degree in a related field (MS, PhD, or MD, DVM) or MBA is preferred.
  • Minimum of 5 years’ experience in the biotech or pharmaceutical industry, with exposure to regulatory activities/submissions and 3 years working on developmental products.
  • Previous regulatory affairs experience is preferred.
  • Experience in working in teams with either a direct or matrix manager.
  • With support, assesses preferred option for tough decisions.
  • Candidates have developing knowledge and understanding of pharmaceutical/biological product development and regulatory requirements for product development and approval in one key region (EU, US, Japan).
  • Experience working in Regulatory Affairs with agency interaction responsibility with at least one health authority is preferred.
  • Relevant experience working in a complex and matrix environment is preferred.
  • Ideal candidates will have clinical or device foundation.
  • Strong ethics and integrity.
  • Developing ability to think strategically, assesses prudent risks and develop bold, agile, innovative approaches to complex challenges.
  • Developing communication skills, with capacity to articulate complex concepts in a manner individuals at various levels in the organization can comprehend with support.
  • Support productive, working relationships within CSL (e.g., R&D and Commercial).
  • Fluency in English (verbal and written).
Benefits
  • CSL employees that work at least 30 hours per week are eligible for benefits effective day 1.
  • We are committed to the wellbeing of our employees and their loved ones.
  • CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters.
  • Our benefits are designed to support the needs of our employees at every stage of their life.
  • Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
regulatory affairsregulatory submissionsproduct developmentModule 1 documentationcore document preparationregulatory filing pathwayregulatory intelligencehealth authority engagementclinical medicinepharmacology
Soft skills
strong ethicsintegritystrategic thinkingrisk assessmentcommunication skillsrelationship buildingteam collaborationagilityinnovationproblem-solving
Certifications
Bachelor's degreeadvanced degree (MS, PhD, MD, DVM, MBA)