Director, Sr. Global Regulatory Lead - Cardiorenal

Das ist der Job

ppThe Director, Senior Global Regulatory Lead (Sr.

Darum lohnt es sich

GRL) in Global Regulatory Strategy (GRS) is a member of the respective GRA GRS Therapeutic Area and contributes to the vision and goals of CSL as follows: /p ul liDevelops a global, integrated regulatory strategy ensuring innovative and scientifically sound regulatory approaches for assigned products, with a patient-centric focus and appropriate risk-taking to achieve successful regulatory outcomes from early development through post-marketing lifecycle activities. /li liActs as a key member and single GRA representative for Product Strategy Teams (PST) and related global RD/commercial teams, while leading the Global Regulatory Affairs Strategy Team (GRAST) to ensure alignment and a unified regulatory voice. /li liLeads health authority interactions (FDA, EMA) and builds productive relationships to drive positive regulatory outcomes globally. /li liEngages GRAST members to deliver regulatory outputs, fosters accountability and collaboration, and serves as decision-maker/approver for regulatory deliverables.

Ensures strong communication between regulatory and RD teams. /li liFor selected roles, manages Regional Regulatory Leads and supports their development and career growth. /li /ul h3Main Responsibilities and Accountabilities /h3 ul liBuilds strong relationships with Product Strategy Teams, Clinical Development Teams, Safety Management Teams, and other stakeholders to ensure effective collaboration and communication. /li liManages strategic relationships with key health authorities (FDA, EMA) and coordinates with regional leads for non-home country interactions. /li liActs as the single GRA reviewer/approver for key deliverables and participates in regulatory due diligence and senior-level discussions. /li liLeads preparation of key regulatory documents and mentors GRAST members. /li liUtilizes regulatory intelligence, analytics, and cross-functional expertise to develop global regulatory strategies. /li liPromotes consistency, collaboration, and knowledge sharing across Global Regulatory Strategy teams. /li liCoaches team members (where applicable) to develop innovative solutions and ensure timely execution of regulatory strategies. /li liApplies CSL leadership capabilities and supports talent development, succession planning, and team empowerment. /li /ul h3Position Qualifications and Experience Requirements /h3 ul liEducation: Bachelor’s degree in pharmacy, biology, chemistry, pharmacology, clinical medicine, or related life science required.

Advanced degree (MS, PhD, MD, DVM) or MBA preferred. /li liMinimum 10 years in biotech or pharmaceutical industry, including at least 8 years in regulatory affairs and 5 years with developmental products. /li liExperience leading teams (preferably 5 years), including decision-making and fostering collaboration. /li liKnowledge of product development and regulatory requirements across major regions (EU, US, Japan). /li liExperience interacting directly with at least one health authority. /li liExperience working in a complex, matrix environment preferred. /li /ul /p