Lead regulatory projects ensuring compliance and representing Conagra Brands in food safety matters. Collaborate across departments to harness regulatory opportunities for business growth.
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
EHS Compliance Specialist supporting regulatory compliance, auditing, and permitting projects at Arcadis. Working with a dynamic team in Ohio, New Jersey, Indiana, and Pennsylvania with a focus on EHS compliance.
Compliance Specialist identifying best practices in mortgage regulations and ensuring compliance with HMDA and ECOA for DAS Acquisition Company. Responsibilities include communication with consumers and tracking loan data.
Vice President of Compliance Governance overseeing compliance governance and risk management within financial services operations. Leading frameworks, reporting, and strategic partnerships with senior leadership.
Senior Associate providing expert service in insurance compliance at ORIX USA. Managing a diverse portfolio while leading junior analysts and ensuring regulatory adherence.
Senior Manager in SAP GRC managing the integration of finance operations at Vodafone. Overseeing compliance and collaborating across teams for effective project management.
Senior Manager of Regulatory Affairs supporting regulatory activities for oncology clinical studies. Collaborating with cross - functional teams to ensure compliance and successful submissions to regulatory agencies.
Compliance Specialist supporting Allegro Group teams by providing compliance management advice. Leading implementation of legal acts and supporting compliance - related training and documentation in Poland.
Director overseeing international regulatory affairs for Capital One, coordinating regulatory activities globally and establishing governance structures. Influencing business strategies and maintaining relationships with international regulators.
Compliance Complaints Advisory Specialist researching and analyzing regulatory guidance on high - risk customer complaints. Collaborating with operations and legal teams to ensure compliance and customer satisfaction.