Electrical Regulatory Manager leading regulatory strategy for new electrical projects at P&G. Collaborating with international teams to ensure compliance and influence regulatory landscapes.
About the role
- Senior Manager Regional Regulatory Lead at CSL Behring developing global regulatory strategies for vaccines. Leading interactions with FDA and EMA and ensuring timely regulatory outcomes.
Responsibilities
- Regulatory leaders who support development of a global, integrated regulatory strategy ensuring innovative, scientifically sound regulatory vision / strategies for assigned product/s with a patient centric-focus, leveraging appropriate business insights and applying prudent risk-taking to ensure timely delivery of successful regulatory outcomes.
- Key member, partner and single GRA representative for the respective Product Strategy Teams (PST) and/or related global R&D/commercial teams, plus leads the corresponding Global Regulatory Affairs Strategy Team (GRAST) ensuring connectivity, ‘One GRA Voice’ and engagement with internal GRAS partners.
- Supporting, potentially leading, health authority interactions in stationed country (FDA or EMA) and maintaining productive relationship and driving positive regulatory outcomes with both FDA & EMA plus global health authorities.
- Engaging GRAST members to achieve regulatory deliverables (including assign tasks) while fostering individual accountability, ‘team spirit’, and act as regulatory decision maker/approver for GRAST / GRA related project deliverables as needed.
- Within GRAST, effectively foster two-communication between GRAST and R&D teams ( e.g. PST), encourage robust regulatory scenario assessment and accountable for delivery of successful regulatory outcomes globally.
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 7 years’ experience in the biotech or pharmaceutical industry, with at least 5 years of regulatory experience, including 3 years working on developmental products.
- Experience in working in teams with either a direct or matrix manager.
- 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 1 health authority.
- Relevant experience working in a complex and matrix environment is preferred.
- Ideal candidates will have a relevant clinical or device foundation.
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.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Alcohol Compliance Supervisor at Jiffy Lube Live ensuring responsible service of alcohol. Supervise event employees, uphold compliance with alcohol service guidelines and interact with guests for satisfaction.
GRC Risk Analyst at Tanium conducting compliance assessments and developing risk management policies. Collaborating with stakeholders to ensure adherence to regulatory requirements and industry standards.
Executive Director leading firm - wide Compliance Risk Assessment program for SMBC Group in financial services. Managing CRA process and collaborating with regulatory stakeholders.
Senior Product Environmental Compliance Specialist leading compliance initiatives in Stryker's Endoscopy division. Driving regulatory strategy and cross‑functional alignment in a hybrid role.
Payments RCA Professional at U.S. Bank focused on operational loss reporting and risk management compliance. Collaborating across teams to ensure timely and accurate reporting and process improvement.
Compliance Representative managing risk and compliance under U.S. Bank's financial services. Involves collaboration across various teams and addressing policy violations and customer complaints.
Corporate Compliance Analyst supporting the development of a global compliance program at Vantage Data Centers. Engaging in risk assessments, training, and compliance monitoring to drive process improvements.
Senior Executive/Executive in charge of compensation and compliance at Orfium, ensuring legal adherence and proper employee relations while managing benefits and compensation strategies.
Compliance Reporting Assistant supporting compliance activities and gaining hands - on experience in a dynamic international environment. Assist in preparing reports and dashboards while collaborating with various stakeholders.