Regulatory Affairs Manager

Job Title

Pay Range: $48.00hr - $53.00hr

Requirement/Must Have:

• 3-5 years of experience with PhD degree, 5-7 with Masters degree and 6-8 years with Bachelor degree in the field of IVDs, Medical devices, Pharma, or Biopharmaceutical with significant experiences in Regulatory Affairs or equivalent.
• Knowledge of XX, US, China, and other international regulations.
• Demonstrated ability to adequately interpret and implement quality standards.
• Demonstrated ability to manage high complexity work and global projects.
• Specialist knowledge in regulatory affairs.
• Experience in solving complex, critical health authority issues.
• Understanding of external environmental changes and precedents to navigate complex situations.
• Demonstrated experience and knowledge of Daily Management and Continuous Improvement best practices.

Responsibilities:

• Ensure products obtain regulatory approvals in defined markets in close cooperation with other functions.
• Coordinate and compile documents and deliverables for submissions in a timely manner to support planned product registration timelines.
• Maintain obtained regulatory approvals and licenses throughout the life cycle of the product by applying successful regulatory change controls.
• Maintain efficiency and success of regulatory activities and strategies through clear agreements with other functions, stakeholders, and external partners.
• Communicate and implement regulatory requirements and strategic aspects within the organization.
• Oversee the development of submission and product registration dossiers for complex products and programs.
• Develop and manage parts of comprehensive global regulatory submissions and registration plans.
• Partner with stakeholders to understand and provide best solutions.
• Develop external relationships that influence the current and future direction for products.
• Contribute to audit preparation and participate in audit discussions.
• Lead the organization to adapt to the evolving regulatory environment and requirements.
• Create unique and innovative regulatory strategies to avoid regulatory obstacles and accelerate worldwide approvals.
• Initiate activities independently and manage interactions across departments.
• Troubleshoot issues as they arise and implement cost-effective solutions to ensure daily work is completed without jeopardizing compliance.
• Identify problems before they occur and drive mitigation strategies.
• Mentor junior regulatory employees and share knowledge across the organization.
• Manage regulatory data and promote data stewardship within regulatory affairs teams.
• Contribute to projects with an understanding of how business functions, systems, processes, and data management are connected.

Nice to Have:

• Knowledge of international regulations and quality standards implementation is considered an advantage.

Skills:

• Regulatory Affairs.
• Submission Compilation.
• Stakeholder Management.
• Strategic Planning.
• Change Control.
• Audit Preparation.
• Decision Making.
• Problem Solving.
• Agile Mindset.
• Data Stewardship.
• Strong verbal and written communication skills.
• Excellent communication and presentation skills.
• Ability to communicate effectively with stakeholders.

Qualification And Education:

• Bachelor’s, Master’s, or PhD degree in a relevant field (IVDs, Medical Devices, Pharma, Biopharmaceutical).