Consultant, Regulatory Affairs

Molecular Templates, Inc. (MTEM) is a clinical stage biopharmaceutical company focused on the discovery and development of biologic therapeutics for the treatment of cancer and other serious diseases. The company primarily develops a pipeline of therapies through its proprietary biologic engineered toxin body (ETB) drug platform with unique mechanisms of actions which are highly differentiated from antibody drug conjugates (ADCs). MTEM is developing MT-6402, which is in a Phase I clinical trial for PD-1/PD-L1 antibody relapsed/refractory patients; MT-5111, which is in a Phase I clinical trial for the treatment of HER2-positive cancers; and MT-0169, which is in a Phase I clinical trial to treat relapsed/refractory myeloma. Additional preclinical compounds derived from our ETB platform technology are being advanced toward clinical development.  Additional information about MTEM can be obtained at www.mtem.com.   

 

 

Position Overview: 

 

 

We are seeking an experienced Regulatory consultant that will serve as the Lead for products while managing, reviewing, planning, and preparing complex regulatory submission documents for global regulatory filings. Among other responsibilities, this role will interpret regulations and provide regulatory guidance to global regulatory teams. You will have 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 is required.  

 

 

Reporting Structure:

 

This position does not have any supervisory responsibilities. This position reports to the Sr. Director, Regulatory Affairs

 

 

MolecularTemplatescelebrates and supports our differences and is proud to be an Equal Employment Opportunity employer.  We do not discriminate based upon race, religion, color, national origin,sex(including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, veteran status, disability, or any other legally protected characteristic.

MTEM is committed to providing reasonable accommodations for qualified individuals.  If you need assistance with your application due to a disability, you may contact us at: careers@mtem.com. 

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