Regulatory Affairs Manager

Essential Duties and Responsibilities:

• Develop and execute regulatory cluster strategy and plans aligned with business for complex projects including new products and maintenance of licenses/ authorizations for existing marketed products.
• Provide technical and strategic input for regulatory decisions aligned with business strategy.
• Identify & prioritize key areas of risk and probability of occurrence as well as ensure implementation of mitigation plans and follow ups
• Monitor, evaluate, and interpret applicable cluster country regulatory requirements, assure compliance with Baxter and external standards
• Assess impact of new regulations with regional impact and provide feedback.
• Maintain appropriate communication within the RA function, with cluster Marketing, and with other functions primarily at the project team level
• Plan and manage complex projects and prioritize workload
• Ensure regulatory strategy and deliverables are aligned with project teams and business objectives.
• Develop and execute role-based regulatory plans aligned with business needs.
• Work with Country RA teams to align submission strategy and support dossier delivery.
• Represent the RA function on cluster assigned cross-functional project teams.

Education & Experience:

• Bachelor’s degree or country equivalent in a scientific discipline
• Master’s degree or PhD and advantage
• Minimum 8-year experience in drug or medical device RA or QA work including management of people.

• Strong regulatory knowledge on medical device regulatory laws in different countries (preferably SEA

• Technical knowledge and management skills

• Ability to manage complex projects and timelines in a matrix team environment

• Strong interpersonal, communication and presentation skills

• Strong negotiation skills

• Ability to lead and coach others

  Excellent organization skills

Reasonable Accommodations

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