Lead the Regulatory Operations project team, providing guidance on regulatory standards, advising on strategies, delivering training, recruitment, workforce planning, and personal development
Manage eCTD submissions, ensuring they are tracked accurately and in full compliance with regulatory guidelines
Participate in development of internal processes for eCTD
Recruitment and training of regulatory personnel for eCTD submissions
Oversee the global publishing, compilation, filing, and maintenance of regulatory submissions
Maintain positive and productive relationships with internal and external stakeholders, including regulatory agencies, clients, colleagues, and staff
Coordinate with country-specific regulatory affairs personnel to support international submissions and registrations
Engage with regulatory agencies and standards development bodies (such as ICH, CDISC, and HL7) to stay informed about new developments in electronic regulatory standards
Lead the implementation of new regulatory standards, processes, and SOPs within the department
Requirements
Bachelor's degree or equivalent experience in a relevant field
Proven experience working with eCTD submissions
Demonstrated ability to produce high-quality work with strong attention to detail
Experienced in creating and delivering effective training materials
Strong leadership skills with the ability to support and guide team members with both compassion and confidence.
Benefits
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
Junior/Intermediate Lawyer handling Compliance and Investigations at a respected law firm in Brazil. Focusing on integrity programs and due diligence processes while fostering client relationships.
Regulatory Affairs Analyst at ICL analyzing compliance and collaborating with teams on regulatory issues. Contributing to high - performance agriculture solutions in Brazil.
Junior Analyst in Vulnerability Management and Compliance at Tempest, focusing on technical guidance and vulnerability assessments. Collaborating with experts and working in a tech - driven environment.
Regulatory Policy Specialist developing regulatory case filings and strategies at Xcel Energy. Collaborating with senior management to ensure compliance and effective communication with stakeholders.
Lead, Insurance Product Compliance offering guidance on compliance risks and solutions for insurance underwriting. Collaborate with stakeholders and perform data analysis to recommend compliance actions.
Compliance Manager overseeing Fair Lending Program at Regions Bank. Directing compliance reviews, advising leadership, and managing training and oversight initiatives.
Commercial Compliance Analyst supporting launch and compliance of commercial field teams at Syneos Health. Collaborating across teams to ensure adherence to regulatory requirements and develop training.
Compliance Analyst responsible for operational execution of licensing program for Nuvei. Handling regulatory reporting, license maintenance, and governance metrics.
Partner Commercial Manager focusing on license compliance strategies for AVEVA’s software revenues in India. Collaborate with sales and legal teams to ensure compliance and drive growth.