FLSA Classification: Exempt/Salary
Schedule:Monday – Friday; 8:00 am –5:00 pm
Department:Regulatory Affairs - US
Reports to: US Senior Director Regulatory Affairs
Supervisory responsibilities: No
Location: Fully Remote
Position Summary/objective:
The Regulatory Affairs Manager will be responsible for leading submissions for all projects in the US and will have oversight of the US regulatory submission processes and tasks.
Essential functions:
Main responsibilities as submission lead
Current role is submission lead for all projects in the US
Leads and has oversight of regulatory submission processes and tasks, including reviewing and compilation of regulatory submissions, coordination of regulatory CROs, the regulatory filing (TMF/eTMF) and archive process
Management, preparation and submission of initial IND/BLA applications and amendments to the FDA
Oversight of eCTD publishing vendor and process
Directs all aspects of the regulatory submission including submission strategy in collaboration with the RA project lead
Ensures compliance with regulatory requirements and timely preparation of formally and scientifically valid applications
Interacts as the company representative with external contacts for regulatory functions, including clinical and business endeavors
Maintain regulatory document archiving and tracking databases
Maintain knowledge of applicable US regulations and guidelines
Secondary functions:
Manages and directs DSUR reports. Supports the collection, review, and incorporation of data into the assigned project DSUR report. Interacts between the safety CRO and the US submission CRO regarding SUSAR submissions to FDA
Review, authoring and editing of SOPs that include RA responsibilities as assigned
Competencies:
Ability to coordinate tasks and effectively work in a highly regulated environment with cross-functional international stakeholders
Excellent organization and time management skills
Manage issues proactively, manage conflicts, and mitigate regulatory risks
Experience with eCTD and document management systems
Experience with clinical trial registries
Experience with vendor management
Strong verbal and written communication skills
Work environment:
This position is remote and should be performed in an office setting that simulates the work office environment. This office must be set up in a way that allows for privacy and quiet during work hours, as well as a comfortable chair and desk. This position uses phone, computer, office equipment and supplies on a regular basis. Noise levels should be at a level which would allow for proper communication with other members virtually.
Physical demands:
Communicating Verbally – expressing or exchanging ideas by means of the spoken word to impart oral information to others to convey detailed spoken instructions or other workers accurately, loudly or quickly.
Hearing – the ability to hear, understand, and distinguish speech and/or other sounds one-on-one, group or conference, telephone, and other sounds.
Keyboarding – entering data or text into a computer or other machine by means of a keyboard. Devices include a traditional keyboard, 10 key-pad, touch screens and others.
Near Visual Acuity – clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).
Sitting – remaining in a sitting position for at least 50% of the time.
Standing/Walking - remain on one's feet in an upright position at a workstation.
Travel required:Some travel is required -may require travelling domestically a few times per year or internationally once per year
Required education and experience:
A bachelor’s degree (e.g., biology, chemistry or pharmacy) or
Minimum of 4-5 years of experience in Regulatory Affairs for pharmaceutical industry
Strong knowledge of global regulations and GxP quality guidelines
Preferred education and experience:
A master’s degree in regulatory affairs, a life science, or business administration is a plus
Experience with biological drugs and/or gene & cell therapy in oncological indications is a plus
Work authorization/security clearance requirements:
Legal eligibility to work in the United States is required. Immatics participates in E-Verify and all new employees will be subject to the Department of Homeland Security requirements for employment.
Affirmative Action/EEO statement:
Immatics is an equal opportunity employer. All employment decisions including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, national origin, ethnicity, marital status, age, physical or mental disability, medicalconditions, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local law.”
Other duties:
Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.This job description may not cover all duties that take place on a daily basis and may be changed as business needs change.Employee will be responsible for adapting and learning the duties as described above or as the new ones are introduced.
United States
