Regulatory Affairs Manager executing and coordinating registration projects for biocidal products at LANXESS. Collaborating with teams and authorities to navigate regulatory topics and interpret material compliance.
About the role
- Director CMC regulatory at Ipsen providing strategic oversight of regulatory processes and systems. Collaborating with stakeholders to enhance regulatory efficiency and effectiveness.
Responsibilities
- Provide strategic and technical CMC regulatory input to improve processes and facilitate interfaces with stakeholders
- Responsible for mapping CMC regulatory activities at the different locations
- Ensure processes, systems and corresponding metrics are in place
- Lead and drive the development and implementation of a sustainable improvement system
- Contribute to the establishment of a culture of continuous improvement mindset
- Establish process to initiate, plan, execute, monitor, and report on the overall CMC regulatory Portfolio activities
- Create visibility and reporting on CMC regulatory portfolio
- Ensure a CMC regulatory platform is built and maintained
- Ensure effective and collaborative working relationships within the Global CMC-Reg teams and all other associated functions/stakeholders
- Support line manager on budget/ resource planning and monitoring for CMC projects.
Requirements
- Advanced degree in scientific discipline, major in pharmaceutical/Biological/Chemical Science or relevant scientific discipline
- Minimum 10 years’ experience in CMC regulatory affairs field in a management role
- Significant depth of change management experience
- Proven ability to communicate (written/oral) with various functions.
- Fluency in English
- Ability of cross functional co-operation.
- Strong ownership and cross boundary working mindset.
- A strong capability in problem solving.
- Strong ability of lobby, influence, and negotiation
- Strong ability to map and define end to end processes.
- Continuous improvement mindset
- Ability to coordinate, influence and lead people or a virtual team.
Benefits
- EHS responsibilities
- Respect and enforce applicable EHS regulations and procedures.
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Head of Risk & Compliance responsible for building frameworks and ensuring compliance at Penfold. Leading a team and enabling product delivery while adhering to regulatory requirements.
Regulatory Affairs intern supporting compilation of Annual Reports and PADERs at Cosette Pharmaceuticals. Engaging with experienced professionals in a collaborative, learning environment.
Consultant - Forensics handling cyber security incident investigations for reputation management. Developing responses to security incidents leveraging forensic tools and incident response strategies.
Manager overseeing compliance and investigations in Forensic & Integrity Services at EY. Leading teams on compliance projects while building client relationships in a dynamic environment.
Vulnerability & Compliance Management Consultant performing vulnerability assessments and compliance reporting at Capgemini. Supporting infrastructure across Linux, Windows, and cloud environments with automation contributions.
IT Access Governance and Compliance Manager ensuring governance adherence and execution of compliance operations. Collaborating with IT teams to enhance control processes and frameworks within BAT.
Team Lead for VAT Compliance in a hybrid role overseeing compliance teams and processes. Leading operational standards and addressing VAT regulatory requirements in an international environment.
Senior Compliance Risk Manager ensuring Mercury products meet regulatory standards. Collaborating with cross - functional teams in compliance advisory for Payments, Lending, or Credit Cards.
Internal Auditor executing compliance and audit duties for security at International SOS. Collaborating with internal stakeholders to enhance information security practices.