Regulatory Affair Specialist

Day to Day Responsibilities:

• Research and interpret regulations to apply to appropriate product lines. 
• Document and maintain regulatory procedures, work instructions, or policies for Asia area. Recommend changes to procedures in response to changes in regulations or standards.
• Review electrical equipment standards and advise on applicability as necessary.
• Review promotional materials, labeling, specification sheets, or test methods for compliance with applicable regulations and policies.
• Conduct New Product Review using SharePoint based system.
• Participate on new biological product project teams and provide inputs for premarket regulatory requirements, labeling requirements.
• Review proposed product or manufacturing changes for regulatory impacts. 
• Interpret regulations or regulation changes, communicate information cross-functionally and updated in division procedures.
• Support external audit related to regulatory ( eg : NMPA )
• Prepare and support responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires. 
• Support post-market surveillance, vigilance, field action and other activities.
• Develop, track and maintain metrics.
• Support interactions and communications with health authorities, regulatory bodies, and customer requests.
• Develop and conduct employee training on regulatory affairs topics.
• Compile and maintain regulatory documentation databases or systems. 
• Work with Division regulatory team to ensure Asia area regulatory compliance.
• Other Duties as assigned.
   

Education & Experience

Required

• Bachelor’s degree in technical specialty (Chemistry, Biology or similar field).
• Minimum of 4 years of quality/regulatory experience in the Life Science/ Pharma or Biotechnology industry.

Desired                                    

• Bachelor

Desired Skills

• Direct experience interacting with governmental agencies. 
• Experience in cGMP and/or GLP.
• Desired skills & experience with managing and submitting regulatory dossier/applications. 
• Desired experience with CTD/eCTD submissions

Soft Skills

• Ability to work across matrix organizations. 
• Excellent communication and organization skills required. 
• Strong attention to detail and analytical/problem-solving skills. 
• Project management skills and ability to work on multiple projects. 
• Experience with regulations related to biopharma products or medical device, IVD 
• Experience with ISO 13485, 21 CFR 211/210, or ISO 9001
• Experience with electronic document management systems (EtQ or similar)
• Fluent oral/written English communication skills
• Flexibility; ability to work in a dynamic environment while managing multiple priorities.
• High sense of urgency.
• Proficiency in MS Office applications (EXCEL, Access), Peoplesoft, Proficy.