Regulatory Affairs Operations Lead

Pittsburgh, PA
Full Time
Regulatory Affairs
Mid Level

Regulatory Affairs Operations Lead

About Krystal Bio:

At Krystal Biotech, Inc., we bring together the brightest and most eager minds to relentlessly pursue the discovery, development and delivery of transformative medicines for people with serious and life-threatening genetic diseases. Founded in 2016, the Company is the leader in redosable gene therapy with prominent clinical and pre-clinical stage programs for dystrophic epidermolysis bullosa, TGM1-deficient ARCI, Netherton Syndrome, Cystic Fibrosis, alpha-1 antitrypsin deficiency, and is advancing research to apply our technology to these and other diseases. The Company’s innovation is fueled by visionary leadership within an entrepreneurial organizational structure with a robust pipeline of investigational medicine.

Our US headquarters is in Pittsburgh, PA with other offices located in Boston, MA and in Zug, Switzerland. For more information about the Company’s platform, commitment to patients and pipeline, please visit http://www.krystalbio.com and engage with us on Twitter and LinkedIn.

We have an exciting journey ahead and a tremendous opportunity for growth, and now is the time to make a meaningful impact on the lives of our patients!

 

Job Description Summary:

Krystal Biotech, Inc is seeking a highly motivated Regulatory Affairs Operations Lead to support all regulatory activities from product development and pre-clinical through product approvals.  They will play an active role in preparation of regulatory documents and ensuring submissions are quality in nature and on-time.

Responsibilities will include, but are not limited to, the following:

  • Expertise in electronic Common Technical Document (eCTD) format and structure
  • Act as business owner for regulatory information systems
  • Lead regulatory submission planning - maintain calendars and schedules to ensure submissions are handled in appropriate timeframes
  • Lead preparation of regulatory documents that meet appropriate standards by creating bookmarks, hypertext links, etc. using eCTD publishing tools and document management systems
  • Lead regulatory submission publishing – including editing, formatting, tracking, compiling regulatory submissions
  • Work cross-functionally with different departments, including Clinical, Product Development, Quality, Manufacturing, and others to ensure accuracy or information provided in submissions
  • Identify process improvement opportunities within regulatory and IT, including creation and refinement of procedures and implementation of systems that enable operational excellence and compliance
  • Manage relationships with business partners

Requirements and Preferred Qualifications:

  • 7+ years of regulatory experience in a Pharmaceutical/Biotechnology environment
  • Experience with regulatory submissions in eCTD format in Veeva, ideally US and EU
  • Excellent communication skills are required
  • A demonstrated self-starter who is highly motivated and able to address changing priorities
  • Ability to take a proactive approach on the job with the ability to work with a dynamic team 

 

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender perception or identity, national origin, age, marital status, protected veteran status, or disability status. Headhunters and recruitment agencies may not submit resumes/CVs through this Web site or directly to managers. Krystal Biotech, Inc. does not accept unsolicited headhunter and agency resumes. Krystal Biotech, Inc.  will not pay fees to any third-party agency or company that does not have a signed agreement with Krystal Biotech, Inc. 

 

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