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: Exempt/salary
Schedule: Monday to Friday, 8:00 AM-5:00 PM; Evenings and weekends as needed
Department: Regulatory 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 conditions, 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.
For more information and to apply, please go here.