Regulatory Affairs Manager
- Employer
- Molecular Templates, Inc.
- Location
- Jersey City, NJ, USA
- Start date
- Oct 20, 2020
View more
- Discipline
- Regulatory, Regulatory Affairs
- Required Education
- Bachelors Degree
- Position Type
- Full time
Job Details
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
Company
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.
OWNERSHIP: Public
STOCK SYMBOL: MTEM
STOCK EXCHANGE: NASDAQ
- Website
- http://mtem.com/
- Phone
- 512-869-1555
- Location
-
9301 Amberglen Blvd, Ste 100
Austin
TX
78729
US
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert