Regulatory Affairs Specialist

West Babylon, NY
This prestigious BioTech/BioPharma with a global reach has a key opening for a Regulatory Affairs Specialist in their Long Island NY offices.
 
 
The Regulatory Affairs Professional will be responsible for ensuring that regulatory strategies and regulatory activities are effectively executed to meet the business objectives and legal requirements.
 
 
This position will organize regulatory information, track and control submissions and provide guidance and advice to internal stakeholders.
 
 
 
Main Responsibilities & Tasks:
 
 
• Manage the activities of Regulatory Affairs within the field of responsibility ensuring the implementation of appropriate and effective regulatory strategies
 
• Provide expert regulatory input to strategic decision making; including review, prioritization, and external communications
 
• Support the development and establishment of policies and standards
 
• Coordinate successful submissions and approval of applications
 
• Plan, undertake and oversee regulatory inspections
 
• Liaise and negotiate with regulatory authorities
 
• Provide advice about regulations to relevant stakeholder
 
• Review and report overall quality status
 
• Keep up-to-date with changes in regulatory legislation and guidelines
 
 
 
 
Qualifications & Skills:
 
 
• Bachelor degree in a science or related field
 
 5+ years relevant experience within the Regulatory Affairs discipline
 
• Deep knowledge of the relevant Regulatory requirements
 
• Thorough understanding and demonstrated ability to apply Regulatory guidelines/regulations
 
• Ability to develop innovative strategies and creative solutions within the Regulatory context and within the scope of requirements/available resources
 
• Proven analytical skill and technical/scientific competence
 
• Ability to appropriately assess risks
 
• Strong initiation and organizational skills
 
• Extraordinary communication skills, with ability to influence others and negotiate successful outcomes
 
• Proactive, quick learner and independent worker able to effectively multi-task in a strongly growing organization
 
• Team-player, able to positively influence Team members at all levels