Senior Specialist - Regulatory Affairs

What Will You Do:

• Assess regulatory intelligence for supporting development of local, regional, and global regulatory strategies.
• Evaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle to ensure product compliance and anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions.
• Assist in the development of regulatory strategy and update strategy based upon regulatory changes.
• Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
• Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization and communicate with regulatory authorities throughout the product lifecycle.
• Identify the need for new regulatory procedures, SOPs, and participate in development and implementation and help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
• Provide regulatory input and technical guidance on global regulatory requirements to product development teams and advise stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
• Evaluate proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and propose plans/strategizes (if appropriate) for changes that do not require submissions.
• Ensure that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.
• Prepare and submit electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
  

What Will You Need:

Basic Qualifications:

• BS in Engineering, Science, or related degree; and MS in Regulatory Science.
• Typically, a minimum of 4 years of relevant experience.
• MS or RAC(s) preferred.
  

Preferred Qualifications:

• Good communication, good mentorship skills, stakeholder and time management skills, writing, coordination, and execution of regulatory items.
• Demonstrates knowledge and skills in areas such as regulatory pathways, risk-benefit analysis, communication and collaboration internally and externally, submission, registration, obtaining approval, documentation, compliance, post marketing surveillance/vigilance and distribution.
• Power platform skills and expertise in MS suite