Regulatory Manager

Qualifications:

• Minimum Required:
• Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
• Computer literacy (MS Office/ Office 365)
• Fluent in English
• Preferred:
• Graduate, postgraduate
• Possesses basic understanding of financial management
• Other Required:
• 5 + years or more relevant regulatory affairs experience
• Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones
• Specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions
• Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
• Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied
• Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
• Availability for domestic and international travel including overnight stays
• Competencies
• Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities
• Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates
• Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
• Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment
• Motivates other members of the project team to meet timelines and project goals
• Flexible attitude with respect to work assignments, and new learning
• Resolves project related problems and prioritize workload to meet deadlines with little support from management
• Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
• Collects data of consistently high standard
• Communicates both verbally and in written form in an acceptable manner
• Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency
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