Careers

Openings

Manager, 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 regulatory strategy and operations.  This will be a very visible role within the company, provide an opportunity to help lead the buildup of a fresh, exciting and innovative patient-focused organization.

 

Reporting to the Head of Regulatory Affairs, the incumbent will have a key role in helping shape the Regulatory Affairs group. It is essential that the incumbent be an experienced regulatory professional and a team leader.

 

The Manager of Regulatory Affairs will drive the development and implementation of regulatory strategies and operations ensuring timely delivery of regulatory submissions.

 

Initially, there will be a focus on pre-IND and IND environments and buildup of regulatory operations within the Regulatory Affairs group.

 

The individual in this role will work closely within the regulatory function and with all other company functions in support of product development, with the goal of delivering regulatory milestones for the company’s programs.

  

Responsibilities

 

  • Provides regulatory strategy and operational support in a timebound manner to product/portfolio assignments, including but not limited to general regulatory strategies, regulatory requirements in domestic and international markets, and regulatory submission requirements.

  • Leads the preparation and submission of documentation to support investigational and marketing registration packages and ensures timelines are met.

  • Reviews IND/CTA, BLA/MAA, and other global submission documents to ensure regulatory requirements are met and in compliance with global regulations.

  • Builds partnerships with other functional areas to ensure strong, clear communication and to identify and address issues in the management of content for regulatory submissions.

  • Develops and implements regulatory submission project and resourcing plans, establishes goals, and measures progress toward critical milestones for major regulatory submissions.

  • Manages vendors as needed to support regulatory submission goals

  • Liaises and negotiates with global regulatory authorities to ensure timely regulatory approvals.

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

  • Facilitates the development of internal and external regulatory policies, guidance, and standards, manages internal regulatory procedures to ensure compliance.

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

Basic Qualifications

  • A minimum of 6 years in the biotechnology or pharmaceutical industry, 3 of which are in Regulatory Affairs.

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

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

  • Proven organizational skills to successfully plan for and manage simultaneous regulatory submissions while managing the routine daily maintenance of existing regulatory applications.

  • Experienced in managing regulatory submission projects to ensure the overall development program objectives and milestones are met.

  • Expertise using MS Office software suite, including Word, Excel, Visio, and Project.

  • Strong interpersonal skills with the ability to motivate others, influence without authority, and negotiate conflict situations

  • Proven ability to distill complex plans across multiple programs into an intuitive, clear communication tool to facilitate prioritization and resourcing.

 

Preferred Qualifications

  • Prior biologic experience preferred.

  • Proven knowledge and experience in cell and gene therapeutic development process and global pharmaceutical laws and regulations.

  • Experience in regulatory submission to global Health Authorities.

  • Life sciences field education and experience.

  • Advanced degree preferred.

 

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.

APPLY ONLINE

APPLY ONLINE

Legal  |  Privacy  |  Cookies

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

+1 215 966 1600

© 2018 Tmunity Therapeutics. All rights reserved.