Regulatory Affairs Manager

Location
New York, NY, USA
Posted
Nov 18, 2020
Ref
195714
Required Education
Bachelors Degree
Position Type
Full time
Company Description:

Molecular Templates is a clinical stage biopharmaceutical company focused on the discovery and development of differentiated, targeted, biologic therapeutics for cancer. We believe our proprietary biologic drug platform technology, referred to as engineered toxin bodies, or ETBs, provides a differentiated mechanism of action that may address some of the limitations associated with currently available cancer therapeutics. ETBs utilize a genetically engineered form of Shiga-like Toxin A subunit, or SLTA, a ribosome inactivating bacterial protein, that can be targeted to specifically destroy cancer cells. Additional information about Molecular Templates can be obtained at www.mtem.com.

Position Overview:

The Manager serves as the Regulatory Lead for products while managing, reviewing, planning, and preparing complex regulatory submission documents for global regulatory filings. Among other responsibilities, the Manager will interpret regulations, and provide regulatory guidance to global regulatory teams. The Manager has the authority to submit complex submissions and may act as primary MTEM contact with US FDA and may lead selected US FDA meetings while ensuring technical accuracy and regulatory compliance of submissions.

Job Responsibilities:
  • Manage the preparation, submission, and maintenance of regulatory submissions for US and Canada including, but not limited to INDs/CTAs, BLAs/MMAs, amendments, orphan drug applications, pediatric study plans, annual reports, and Investigator's Brochures
  • Support CROs on global regulatory submissions including, but not limited to provision of regulatory documents and regulatory submission strategy
  • Assist in coordination and preparation for Agency meetings and associated briefing document preparation.
  • Manage and supervise queries and commitments with regulatory agencies, collaborate with SME's to provide written responses to queries, provide periodic status updates regarding conditions/commitments.
  • Lead or support development of DSUR, and any additional submission documents.
  • Maintain knowledge of regulatory requirements, comment on draft regulatory guidance, and communicate changes in regulatory information as needed
  • Facilitate and oversee arrangements with external regulatory consultants and providers
  • Interface with CMC, nonclinical and clinical teams on regulatory-related activities

Qualifications:
  • Bachelor's degree in Life Sciences required, PharmD, Masters in Regulatory Affair/Science or Public Health or RAC certification preferred.
  • 2 Years of Regulatory submission experience required.
  • Knowledge of US FDA and international pharmaceutical requirements, regulations, drug development process, and industry practices
  • Experience with IND, and/or NDA/BLA submissions preferred.
  • Strong organizational, writing, problem solving, collaboration and communication skills

Reporting Structure: This position will not have supervisory responsibilities. This position reports to VP of Regulatory Affairs.

Molecular Templates, Inc. is an Equal Opportunity Employer and offers competitive salaries and benefits.

Molecular Templates Inc https://mtem.isolvedhire.com