Job Description:

The Senior Regulatory Affairs and Compliance Specialist will be responsible for coordinating, planning, preparation, assembly, and review of regulatory submissions to the FDA and other worldwide regulatory agencies.

Responsibilities

• Develops domestic and/or international strategy for regulatory approval of company products


• Coordinates, compiles, and submits U.S, and/ or International regulatory submissions, including
  
  
  
  • filing and/or creation of Drug Master Files (DMFs)
  
  
  • Supplements
  
  
  • Change Notifications
  
  
  • Other country-specific product registrations
  
  


• Prepares robust regulatory applications to achieve departmental and organizational objectives


• Represents Regulatory Affairs on cross-functional product development and manufacturing support teams


• Acts as a liaison between Aldevron and the various appropriate regulatory agencies, ensuring that communication on both sides are germane, specific and that they convey all necessary details


• Maintains ongoing surveillance and analysis of pertinent domestic and international regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel


• Reviews product labeling and marketing materials for compliance with FDA submissions and applicable regulations


• Interfaces directly with U.S. Food and Drug Administration (FDA) and other regulatory agencies


• Conducts reviews of product and manufacturing changes for compliance with applicable regulations


• Complies with FDA and international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.

Required Skills

• Experience with regulatory submissions including Drug Master Files (DMFs), Supplements, Change Notifications, and country specific registration requirements


• Proficient with MS Office Suite (Word, Excel, PowerPoint, Outlook)


• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization


• Experience working with and communicating with the FDA and other regulatory agencies

Must-Haves

• 5+ years of technical experience, including at least 4 years of regulatory experience


• Bachelor’s Degree in life sciences, engineering, or other technical discipline

Work Hours/Shift

Monday-Friday – 8 am – 5 pm

Join Us Today!

Join a team committed to making lives better. Aldevron provides high-quality plasmid DNA, proteins, enzymes, antibodies, and other biologics to help our partners achieve significant breakthroughs for a variety of life science applications.

If you would like to thank someone for referring you to this role, please apply at www.aldevron.com/careers, and include their first and last name as a referral source!

Aldevron is committed to equal opportunity for all employees and applicants. We are committed to creating a diverse workforce and consider all qualified applicants without regard to race, religion, color, sex, national origin, age, sexual orientation, gender identify, or protected veteran status among other factors.

 

 

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

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