About the role:
We are looking for a highly skilled and experienced individual to join our team as an Associate Regulatory Affairs Director. The successful candidate will be responsible for providing strategic leadership and guidance in regulatory affairs activities to ensure compliance with applicable regulations, standards, and guidelines.
- Develop and implement regulatory strategies for new product development, including regulatory pathways, submission timelines, and risk management plans
- Oversee the preparation, review, and submission of regulatory documents and dossiers to regulatory agencies, ensuring compliance with regulatory requirements
- Ensure ongoing compliance with regulatory requirements, industry standards, and guidelines by maintaining an up-to-date knowledge of regulations, and interpreting and communicating their impact on the organization
- Collaborate with cross-functional teams, including research and development, quality assurance, clinical affairs, and manufacturing, to ensure regulatory compliance throughout product development, manufacturing, and post-market activities
- Monitor and analyze relevant regulatory and industry developments, trends, and changes, and provide guidance on their potential impact on the business
- Serve as the primary point of contact for regulatory agencies and coordinate communication and interactions. Prepare for and participate in meetings, inspections, audits, and other regulatory interactions
- Review and approve regulatory submissions, labeling, promotional materials, and change control documentation to ensure compliance with regulations and guidelines
- Lead and manage a team of regulatory affairs professionals, providing guidance, mentoring, and training to ensure high-quality work and professional development
- Bachelor's degree (or higher) in a Pharmacist or related field
- Minimum of 10 years of experience in regulatory affairs within the pharmaceutical or healthcare industry
- Demonstrated knowledge and understanding of global regulatory requirements, guidelines, and standards
- Strong analytical and problem-solving skills, with the ability to interpret and apply complex regulatory information
- Proven leadership and team management abilities, with the capacity to motivate and develop a high-performing team
- Excellent communication and interpersonal skills, with the ability to effectively collaborate with cross-functional teams and interact with regulatory agencies
- Ability to prioritize multiple tasks and projects, meet deadlines, and adapt to changing priorities in a fast-paced environment
- Fluent in English
If you are a highly motivated and dedicated regulatory affairs professional looking to take on a leadership role and contribute to the success of our organization, we encourage you to apply. This role offer competitive compensation and benefits.
Due to the high volume of applications, our team will only be in touch if your application is shortlisted.
Argyll Scott Asia is acting as an Employment Agency in relation to this vacancy.