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Director, CMC Regulatory Affairs

JOB ID:

POSTED: 04/30/2018

 

Job Detail

Tmunity is seeking a strong, purpose driven leader to help build out the company’s capability in CMC Regulatory Affairs.  This will be a very visible role within the company and externally, providing the opportunity to be a part of an exciting, innovative and fast paced patient-focused organization.

 

Reporting to the Head of Regulatory Affairs, the incumbent will have a key role in helping to shape the Regulatory Affairs group.  Critical to this role are strong CMC regulatory strategy and leadership skills, preferably experienced in Cell and Gene CMC development. 

 

The Director, CMC Regulatory Affairs, will drive the development and implementation of the global CMC regulatory strategy focusing on both pre-IND and IND environments, working to ensure timely delivery of regulatory milestones and approvals for the company’s programs.  

 

The individual in this role will be working closely with the process development and manufacturing team, as well as other key company partner teams to ensure successful technology transfer and manufacture buildup.

 

Key to the success of the role will be the ability to foster and enable close collaboration with the regulatory function and all other key functions – team collaboration and cross functional influencing skills are a must.

  

Responsibilities

 

  • CMC regulatory leadership, oversight and strategy in support of product/portfolio assignments, including but not limited to CMC regulatory strategies, regulatory requirements in domestic and international markets, regulatory strategic development plans and risk assessments, critical issue management and advice on Health Authority interactions.

  • Liaises and negotiates with global regulatory authorities for CMC development in order to expedite regulatory approvals, including resolution of key regulatory issues.

  • Oversees the preparation and submission of CMC package to support investigational and marketing registration applications throughout the world and ensures timelines are met.

  • Integrates functional expertise with business knowledge to solve problems and make good decisions for the overall business.

  • Builds partnerships with key stakeholders from other functions and corporate partners to ensure that strategic business goals are met through the sharing of knowledge, expertise and the provision of regulatory guidance and insights.

  • Actively monitors current and emerging regulatory and scientific issues and assesses impact on company’s development programs.

  • Proactively influences the development of internal and external regulatory policies, guidance, and standards.

  • Supports project team goals and organizational initiatives, on an as needed basis.

Basic Qualifications

Minimum of following

  • A minimum of 8-10 years in the biotechnology or pharmaceutical industry, 6 of which are in CMC Regulatory Affairs.

  • Demonstrated ability to apply critical thinking, effective problem solving, strong understanding of regulatory strategies and the ability to prioritize multiple tasks.

  • Proven ability to communicate effectively in both a written and verbal format.

  • Demonstrated ability to work collaboratively in a team structure and must demonstrate a proven ability to work well under pressure.

  • Able to foster open communication with a proven record of working with and influencing multi-disciplinary teams.

  • Skilled in conflict resolution/negotiation, and ability to influence the decisions of others using facts, logic and credible personal presence, and to act in the interest of the business to reach agreement with internal/external groups

  • Capable of leading communications with regulatory agencies to facilitate review and approval of submissions.

  • Strong technical leadership skills, as well as demonstrated understanding of pharmaceutical operations (e. g., manufacturing, process development, analytical, quality assurance).

  • Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported by data.

 

Preferred Qualifications

  • Advanced degree in Life Sciences

  • Prior biologic CMC experience

  • Thorough knowledge of the cell and gene therapeutic development process and global pharmaceutical laws and regulations.

  • Experience of filing a BLA for a Cell and Gene Therapy product.

  • Demonstrated experiences of challenges in regulatory CMC as applied to Cell and Gene therapies

  • Global HA experiences in the Cell and Gene space

 

Location

  • Fulltime, based in Philadelphia PA

  • May require travel to East Norriton, PA to Tmunity Manufacturing facility

  • Will require 5-10% travel out of state as part of duties with partners

Tmunity is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

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Tmunity Therapeutics Inc.
3020 Market Street, Suite 535
Philadelphia, PA 19104

+1 215 966 1600

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