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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• Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.
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