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Regulatory Affairs Director

17 June 2021

ABOUT NOVEOME BIOTHERAPEUTICS, INC.

Noveome Biotherapeutics, Inc. is a dynamic biopharmaceutical company with an innovative platform technology that represents a paradigm shift in drug development. Unlike most drugs that are single molecules directed at specific indications, Noveome’s product is a complex mixture of biomolecules that is believed to have the ability to treat a wide range of conditions and injuries. Noveome collaborates with major research centers to advance these therapeutic applications.

POSITION OBJECTIVE

The Regulatory Affairs Director leads and supports the execution of all regulatory activities for the Company’s products. This position is primarily accountable for the success of interactions and negotiations with regulatory agencies on assigned projects and will manage regulatory activities according to corporate goals and timelines. This position will provide regulatory leadership to cross-functional development teams, guide the regulatory strategy to support global development, oversees regulatory submissions to support the drug development process, and maintain positive interactions with regulatory health authorities. The Regulatory Affairs Director will provide the organization with the leadership and strategy to enable high quality and effective health authority and team communications to effectively drive the development process.

WHAT YOU WILL DO FOR NOVEOME

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

  • Provide operational and strategic regulatory input and guidance to cross-functional teams in order to remain informed, compliant, and efficient. Provide broad regulatory support to ensure the delivery of business objectives. Assess regulatory requirements required to achieve product approvals and provides issue resolution to project development teams.
  • Manage all submission activities to ensure the accuracy, timeliness, and quality of regulatory submissions including Investigational New Drug (IND) applications, orphan designations, scientific advice, end of phase I/II meetings, pre-BLA/MAA meetings, annual reports, and amendments in the final review.
  • Lead communication of the recommended “path to approval” for product development teams and actively manage according to development timelines and defined strategies.
  • Monitor emerging trends in the development of new regulatory requirements and guidance documents. Determine potential impacts on business or development programs. Conduct due diligence initiatives including opportunity and risk assessment. Develop and facilitate remediation plans as necessary.
  • Guide activities with the project teams to ensure that all stakeholders are provided with timely and accurate information in accordance with regulatory requirements and development strategies.
  • Manage global regulatory processes to ensure positive outcomes in meetings with health authorities and advisory committees. Accountable to lead successful interactions with the health authorities as necessary to support CMC, clinical and non-clinical submission activities.
  • Provide guidance, technical expertise, and oversight to Regulatory staff and supporting staff including establishing department policies. Ensure department compliance with cGMP, GCP, FDA, EMA, and other regulatory guidelines.
  • Strategically plan for future processes and procedures based on the stage of drug development and growth of the Company.
  • Provide department and executive team with progress reports relating to all regulatory activities. Conduct presentations and group briefings regarding regulatory.
  • Uses the corporate objectives to create department goals that aid the achievement of those objectives. Support the Regulatory Affairs team in establishing individual objectives aligned with the achievement of department goals and encourage professional development.
  • Manage the department needs including budgets, allocation of resources, monitoring expenditures including personnel and regulatory system costs.

Please note, as a company rooted in innovation, our positions are consistently evolving, and we champion the development of all roles. This job description is not designed to contain comprehensive listing of all responsibilities that are required, as they may change to meet the ongoing needs of the Company.

REQUIRED QUALIFICATIONS

  • Knowledge of FDA, EMA, cGCP, cGMP, cGLP regulations, and ICH guidelines
  • Biopharmaceutical drug development, manufacturing, testing, and distribution exposure
  • Early and late stage clinical development programs
  • Regulatory submission management
  • Regulatory agency communication
  • Microsoft Office Word, Excel, PowerPoint, Adobe, Outlook
  • Common Technical Document (CTD) and Electronic CTD format and publishing

BENEFICIAL QUALIFICATIONS

  • Successful U.S. regulatory submission track record
  • Therapeutic complex biologic and cell therapy experience
  • Tissue processing industry environment exposure
  • Post marketing experience with the Office of Prescription Drug Promotion (OPDP)
  • Regulatory submission requirements for drug development including Target Product Profile (TPP) and commercial labeling
  • Knowledge of Rest of World (ROW) Requirements
  • Regulatory Affairs Certifications

ATTRIBUTES OF SUCCESS

  • Interactive
  • Communication
  • Critical Thinking
  • Integrity
  • Customer Focus
  • Persuasiveness
  • Adaptability
  • Collaboration
  • Proactive Thinking
  • Results Oriented
  • Leadership

PHYSICAL DEMANDS/WORK ENVIRONMENT

Subject to extended periods of sitting and/or standing, vision to monitor and typing. Work is generally performed in a temperature-controlled office environment.

REGULAR SCHEDULE

This is a salaried full-time position with a regular schedule of Monday through Friday work hours. Extended hours may be needed on occasion to complete company objectives.

WHAT NOVEOME WILL DO FOR YOU

Noveome provides transparency in expectations, encourages innovative thinking, opportunities for expanded learning, competitive salaries, and a clean safe work environment. Eligible employees will appreciate the comprehensive benefits package and wellness perks.

LOCATION PITTSBURGH

REPORTS TO CHIEF OPERATING OFFICER/SVP REGULATORY AFFAIRS

MANAGES OTHERS NO (May evolve to personnel management role commensurate with company growth)

EDUCATION REQUIREMENTS BACHELOR’S OR MASTER’S DEGREE IN A SCIENTIFIC DISCIPLINE

RELATED DEGREE PROGRAMS BIOLOGY, CHEMISTRY, MICROBIOLOGY, BIOCHEMISTRY

YEARS EXPERIENCE REQUIREMENTS 10+ WITH BACHELOR’S, 7+ WITH MASTER’S FDA REGULATED INDUSTRY EXP 8+ YEARS’ MGMT EXP IN A GMP ENVIRONMENT WITH 3+ SENIOR MGMT EXP IN REGULATORY/QUALITY ASSURANCE

Noveome is an Equal Opportunity Employer.

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