Regulatory Affairs Associate

REG AFFAIRS · Santa Ana, California
Department REG AFFAIRS
Employment Type Full-Time
Minimum Experience Mid-level

Job Title
Regulatory Affairs Associate

 

 

Job Summary

 

NKMax America is seeking a motivated and energetic Regulatory Affairs Associate to manage, evaluate, and complete regulatory submissions consistent with the Company’s goals. This individual will be responsible for supporting the planning and preparation of high-quality INDs/CTAs, amendments, and other regulatory submissions as required. In addition, the Regulatory Affairs Associate will also support the maintenance, archiving, and tracking of regulatory submissions and correspondence interfacing with Regulatory technology and publishing partners.

 

As of now, this is a remote position due to the COVID-19 pandemic.  As restrictions lift, the position will likely transition into being onsite full-time.

 

General Responsibilities

 

Under direction from, and in collaboration with the Director, Regulatory Affairs, the candidate will:

 

  • Assist the preparation, assembly, review, and timely submission of regulatory dossiers as required for investigation and registration of products in the U.S. and abroad.
  • Assist document publishing for regulatory submissions from all areas of the company, in support of active INDs in eCTD format (formatting, publishing, submitting, life-cycling, and archiving sequences) such as CTAs, annual reports, amendments; may include both paper and e-submissions.
  • Assist outsourced publishing and records management vendors, as applicable.
  • Represent Regulatory Affairs in project teams to support submission planning and ensure coordination of system development activities.
  • Reviews submission documents in accordance with the global regulatory standards.

*The company reserves the right to add or change duties at any time.

 

Job Qualifications & Skills

 

  • A Bachelor’s degree in a scientific/health science field.  Advanced scientific degree is a plus.
  • A minimum of 3 years overall regulatory experience in the pharmaceutical/biotechnology industry.
  • Working knowledge of preparation of INDs, supportive amendments (nonclinical, manufacturing, and clinical), CTD/eCTD hierarchy.
  • Working knowledge of FDA and ICH regulatory guidance and regulations.  Knowledge/experience with regulatory requirements for other regions also desirable.
  • Understanding of FDA structure and function.
  • Working knowledge of GLP, GMP, and GCP regulations as well as an understanding of the pharmaceutical product life cycle.
  • Excellent oral and written communication skills.
  • Excellent organizational and planning skills.
  • Detail-oriented, self-starter, and be comfortable with broad responsibilities in a fast-paced, small company environment.

 

Benefits & Perks

 

  • Competitive compensation
  • Medical, Dental and Vision Insurance
  • Business casual work attire
  • Fully stocked kitchen and much more!

 

 


 

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  • Location
    Santa Ana, California
  • Department
    REG AFFAIRS
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level