Returning Candidate?

Regulatory Affairs CMC Manager/ Sr. Manager

Regulatory Affairs CMC Manager/ Sr. Manager

ID 
2017-1078
Category 
Regulatory Affairs
Job Location 
US-MD-Rockville
Type 
Regular Full-Time

More information about this job

Overview

MacroGenics is a leader in the discovery and development of innovative medicines that utilize our next generation antibody-based technologies.  Our team of 300+ dedicated individuals is advancing a pipeline of product candidates to treat patients with cancer as well as various autoimmune disorders and infectious diseases.  Our products and platforms have attracted multiple partnerships with leading pharmaceutical companies around the globe.

 

The Company considers its employees to be its most valuable asset and we are committed to providing opportunities for individuals to learn and grow as a means to further their professional development. MacroGenics' corporate culture promotes an atmosphere of innovation, open communication and teamwork where employees can see firsthand how they contribute to the success of the organization.

Summary of Position

The Regulatory Affairs CMC Manager/Senior Manager will provide regulatory guidance to ensure development activities, manufacturing, and testing for all MacroGenics products are compliant with the relevant regulations, guidelines and industry standards. Responsibilities include collecting, reviewing and assembling CMC-related submission documentation, and ensuring appropriate review and approval of submissions prior to submitting to a Regulatory Authority.

Responsibilities and Job Duties

  • Develop CMC-related submission content outlines and establish submission timelines in collaboration with relevant project team members; manage execution of submission preparation, review, approval and delivery to the appropriate Regulatory Authority
  • Interact with Process Development, Manufacturing, Quality Assurance and Quality Control personnel contributing to a submission regarding content and timelines; ensure sections provided to Regulatory are consistent with regulatory requirements and internal submission format standards; edit content of submissions based on regulatory requirements; reformat sections as necessary
  • Review and provide comments on SOPs, stability protocols, product container labeling, product specifications, comparability protocols and reports, quality agreements, pharmacy manuals, investigator brochures and other related CMC documents
  • Continue professional development by attending regulatory CMC-related meetings applicable to biopharmaceutical products
  • Aid in the implementation of infrastructure necessary for successful completion of regulatory projects (e.g., preparation of Regulatory-related written processes and procedures, review of departmental SOPs, establishment of electronic document standards)
  • Provide support to Senior Director, Regulatory Affairs CMC as requested

Qualifications

Education

 

Bachelor’s degree in a scientific discipline

 

Experience

 

Regulatory Affairs CMC Manager

  • At least 5 years in a Regulatory department at biopharmaceutical/pharmaceutical company working with biologics/large molecules with a proven track record in preparing and submitting high quality submissions that meet regional Regulatory Authorities’ requirements
  • Direct experience assembling Regulatory applications in eCTD format

 

Sr. Regulatory Affairs CMC Manager

  • At least 7 years in a Regulatory department at biopharmaceutical/pharmaceutical company working with biologics/large molecules with a proven track record in preparing and submitting high quality submissions that meet regional Regulatory Authorities’ requirements
  • Direct experience assembling Regulatory applications in eCTD format

 

Knowledge, Skills and Abilities                             

  • Direct experience assembling Regulatory applications in eCTD format
  • Knowledge of FDA, ICH and EMA requirements for biopharmaceutical products required
  • Excellent verbal and written communication skills
  • Strong project management and organizational skills with ability to multi-task on several projects
  • Highly flexible, adaptable and experienced in a fast-paced environment
  • Expertise in MS Office; experience with Electronic Document Management Systems for preparing, formatting, and finalizing regulatory submissions
  • Results driven with demonstrated successful outcomes.
  • Ability and desire to work well with diverse employees and customers in a cooperative and friendly manner.
  • Must possess ability to handle multiple priorities in a fast-paced environment.

 

Supervisory Responsibilities

 

No

 

Preferred Qualifications

  • Advanced degree desirable especially in Regulatory Science, Biotechnology, or Pharmaceutical Science
  • Regulatory Affairs Certification (RAC)
  • Prior experience preparing a BLA
  • Experience with ex-US regulatory submissions

 

Statement

MacroGenics is proud to be an equal opportunity employer. Employment selection and related decisions are made without regard to race, color, national origin, sex, gender identity, sexual orientation, religion, age, disability, protected veteran status, or any other characteristic protected by federal, state or local law. We are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the employment process, please email info@macrogenics.com or call (301) 354-3566 and/or 711 for TTD/TTY service.

Equal Opportunity Employer/Veterans/Disabled

 

For more information about our commitment to equal employment opportunity, please click here.