Senior Director Regulatory Affairs - Military veterans preferred

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Senior Director Regulatory Affairs

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locations

Houston

time type

Full time

posted on

Posted 10 Days Ago

job requisition id

JR100171

It's fun to work in a company where people truly BELIEVE in what they're doing! We're committed to bringing passion and customer focus to the business. FLSA Classification

:

E

xempt/salary Schedule:

Monday to Friday, 8:00 AM-5:00 PM

; Evenings and weekends as needed Departmen

t:

Regulato

ry Affairs Reports to

:

Vice President

, Regulatory Affairs Supervisory responsibilities:

Yes Location:

Remote

or

on

site in Houston

, TX

(at least

4

days in the office hybrid if in

the Greater

Houston

Area

) 13203 Murphy Rd., Stafford, TX 77477 Position

Summary/objective

: We are

seeking

a highly experienced Senior Director of Regulatory Affairs to lead our US Regulatory Affairs department. The successful candidate will

be responsible for

developing and executing regulatory strategies for our product portfolio of cell and gene therapy products and

bispecifics

in the US, ensuring compliance with FDA regulations and guidelines. The Senior Director of Regulatory Affairs will work closely with cross-functional teams to ensure

timely

and successful submissions, approvals, and product launches. Essential functions

: Leads,

manages

and develops the US Regulatory Affairs team

Develops and implements regulatory strategies for Immatics product portfolio in the US

Ensures compliance with FDA regulations and guidelines

Provides guidance to internal teams on regulatory requirements and changes

Monitors and assesses regulatory landscape and provides recommendations for strategic decision-making

Works hands-on with cross-functional teams to prepare and

submit

INDs, BLAs, and other regulatory submissions

Oversees and coordinates regulatory operations and submissions in the US

Proactively manages regulatory submissions timelines and ensures

timely

approvals, stays on top of all

deadlines

and communicates and escalates issues if necessary.

Manages relationships with regulatory agencies and

participates

in meetings with regulatory authorities

Prepares and presents regulatory updates to senior management

Competencies: Ability to lead self and others

Accountable for own role and the role,

strategy

and operations for respective area of responsibility

Ability to act as deputy of A level

Ability to deliver organizational entity/ function and company

objectives

.

Ability to coordinate the development and implementation of performance goals for own area of responsibility.

Ability to pro-actively develop an organizational entity/ function.

Ability to attract and

retain

key talent.

Strong leadership and team building skills, especially for a remote team.

Strong coordination and problem solution abilities.

Manages issues proactively, manages conflicts, and mitigates regulatory risk.

Good organization and time management skills.

Strong oral and written communication skills.

Required education and

experience: Bachelor's degree in a scientific or related field

Minimum of 10 years of regulatory affairs experience in the biotech or pharmaceutical industry

Experience leading regulatory affairs teams in the development and approval of cell and gene therapy products and biological products

Strong knowledge of FDA regulations and guidelines

Experience with INDs, BLAs, and other regulatory submissions

Ability to work cross-functionally and collaborate with internal and external stakeholders

Excellent communication and interpersonal skills

Strong leadership and team management skills

Preferred education and experience

: Master's degree in a scientific or related field.

Work environment: Remote position. If on site, this is a sedentary position (at least 50% of time) in a typical office environment. There may be frequent interruptions with moderate noise levels and frequent use of printers, copiers, scanners,

computers

and other office equipment.

Ability

to sit, talk, walk,

hear

and communicate verbally and in writing is

required

. Occasional lifting of objects up to 25

lbs

is expected. 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.

Lifting

-

raising or lowering an object (up to 25

lbs

) from one level to another (includes upward pulling). Carrying is to transport an object – usually by holding it in the hands or arms

but

may occur on the shoulder.

Near Visual Acuity

– clarity of vision at approximately 20 inches or less (working with small objects, reading small print, including the use of computers).

Pushing

- Exerting force upon an object so that the object moves away from the object.

Pulling

- Exerting force upon an object so that the object moves toward the force.

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.

Stooping

–

occasional bending

the body downward and forward by bending the spine at the waist - requiring full use of the lower extremities and back muscles.

Travel required: Occasionally domestic or international travel

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, medical condition

s

,

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.

Employees will

be responsible for

adapting and learning the duties as described above or as the new ones are introduced.

Welcome!

Please apply using your

FULL LEGAL FIRST AND LAST NAME

as displayed on your government identification.

About Us

Immatics’ fundamental purpose is to apply its technology and drug development efforts toward improving the outcomes for cancer patients through the exciting advances of using the immune system to fight the disease. From its research and development origins in Tübingen, Germany, to its cell therapy center in Houston, Texas and corporate functions in Munich, Germany, Immatics represents a trans-Atlantic team united to build a global leader in T cell receptor-based immunotherapies. We are only accepting digital applications via the application form of each position. For general inquiries on recruiting topics, please write a message to

RecruitingUS@immatics.com

for US recruiting topics.

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