Pioneering the Science of People

Xequel Bio is looking for world-class professionals who possess an unequaled work ethic and customer-centric philosophy within the biopharma industry.

Our culture empowers others to strive for excellence. We consistently aim to motivate and inspire people to do their best – to have conviction in what they are doing to get optimal results. We believe each team member is paramount to the success of the organization. People want to be inspired, and Xequel Bio is doing just that.

Core Values

At Xequel Bio, we strive to conduct ourselves according to these values in all we do, with the ultimate goal that our scientific innovations benefit the patients who need them most.  

We are committed to always do the right thing — accepting nothing less than the highest standards in all we do.

We are committed to investing in innovation. Above all, working with purpose and intention, with the ultimate goal of ensuring our cutting-edge technology fulfills unmet needs and helps patients in new and innovative ways.

We are like-minded entrepreneurs who are relentless in our pursuit of excellence. Our team embraces a growth conviction in pursuit of the extraordinary.

Every team member at Xequel Bio is valued and empowered so that they feel equally involved and supported in all areas of the workplace, regardless of who they are or what they do. We respect one another and embrace our diverse backgrounds and perspectives which allow us all to grow and succeed. We believe that the sum of the whole is much greater than the individual parts.

Are you ready to write the Xequel for your career?

We are always on the lookout for talented, like-minded individuals to join our team. Think you might be a good fit? Apply today — we look forward to meeting you!

Xequel Bio is an equal opportunity employer. 

Open Positions

Location: Nationwide (US)

COMPANY DESCRIPTION:

Xequel Bio, Inc. is a clinical stage biopharmaceutical company advancing its proprietary aCT1 (alpha-Connexin carboxyl-Terminal 1 peptide) technology platform to develop drugs that will enable physicians to better manage a variety of indications involving inflammation and the body’s response to injury. aCT1 is a patented new chemical entity currently in development for multiple indications. The Company’s lead clinical programs include Granexin® gel in dermatology and iNexin ophthalmic solution in ophthalmology.

Xequel Bio’s corporate office is located in Fort Worth, Texas and has a R&D office in Mt. Pleasant, South Carolina.

ABOUT THE POSITION:

The Vice President, Regulatory Affairs reports to the Chief Scientific Officer (CSO). The VP, RA, will be responsible for all Regulatory Affairs across the Company’s portfolio. The successful candidate will work cross functionally with the business having keen focus on CMC/RA for commercial stage products as well as all regulatory Health Authority submissions for the R&D programs.

JOB DUTIES:

  • Accountable for the development, implementation, and maintenance of robust regulatory strategies to support global clinical trial activities, global registrations and product approvals, reintroduction of discontinued products and CMC regulatory compliance throughout the product lifecycle.
  • Build critical relationships with Health Authorities that ensure successful interactions and outcomes.
  • Provide regulatory support for new and ongoing clinical trials (e.g., clinical trial applications and import licenses, provide input for clinical protocols, labels, and other study related materials).
  • Maintain current awareness of relevant global regulatory requirements.
  • Identify and assess global regulatory risks, develop mitigation plans, and communicate changes in regulatory information to departmental and team colleagues.
  • Coordinate regulatory submissions, including strategy for updating existing dossiers and submission of new INDs/CTAs/NDAs/MAAs, etc.
  • Provide hands-on support in generation of regulatory documents.
  • Ensures clinical and nonclinical data—in conjunction with regulatory strategy—are consistent with regulatory requirements and support the proposed product claims.
  • Provide support for cGXP activities as the relate to regulatory affairs (e.g., inspections).
  • Provide support for responding to queries from Health Authorities and for preparing for meetings with regulatory agencies.
  • Monitor progress of the regulatory authority review process through appropriate communication with the agency.
  • Ensure and facilitate communication among executive management, peers and associates; proactively communicate critical situations in an adequate and timely manner to interdisciplinary teams and to appropriate management level in CMC/RA, QA, TechOps and R&D as appropriate.
  • Liaise with all relevant groups to ensure high quality documentation is developed.
  • Collaborate with CSO in all development activities.
  • Contribute senior level operational and strategic regulatory input into BD&L and oversee Due Diligence evaluations.

QUALIFICATIONS:

  • +15 years of experience in global Regulatory Affairs with experience in ophthalmology, pulmonology, and dermatology.
  • Demonstrated leadership excellence in building and maintaining Health Authority relationships, influencing people, negotiation and communication skills.
  • Potential/ability to coach and develop people and teams and to recruit to support the talent pipeline.
  • Excellent working knowledge/experience in regulatory submission and approval processes and proven practical knowledge of and ability to resolve complex CMC regulatory issues.
  • Proven track record of successfully leading teams, planning, coordinating and leading activities simultaneously on multiple projects.
  • Regularly demonstrated active contributions to line functions or project teams.
  • Demonstrated leadership in risk assessment and mitigation, strategic thinking, and maintaining awareness of business impact.
  • Demonstrated ability for innovative, strategic and big picture thinking.
  • Strong interpersonal, organizational, communication, presentation, negotiation and problem-solving skills.
  • Computer literacy (e.g. MS Project, PowerPoint, document management systems) available and shown ability to quickly learn new software, tracking tools and associated processes.

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    Culture

    Our culture empowers others to strive for excellence. We consistently aim to motivate and inspire people to do their best – to have conviction in what they are doing to get optimal results. We believe each team member is paramount to the success of the organization. People want to be inspired, and Xequel Bio is doing just that.