Senior Manager Regulatory Affairs

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FLSA Classification : Exempt/Salaried
Department: Regulatory Affairs
Reports to: Senior Director, Regulatory Affairs
Supervisory responsibilities: No
Location: Onsite in Houston or Remote
Schedule: Monday to Friday; 8:00 am to 5:00 pm, Full-time
PTO: Four weeks of paid time off per year accrued each pay period, awarded at year start.
Position Summary/objective:
The Senior Manager CMC Regulatory Affairs will be instrumental for developing the regulatory CMC concepts and strategies for Immatics' cellular product candidates in close collaboration with the Process Development team, the Manufacturing team as well as with Quality Assurance. A crucial responsibility for this position is authoring and maintenance of CMC documentation for US INDs and EU CTAs. The candidate will have demonstrated the ability to work independently, apply in-depth knowledge of global regulatory CMC requirements and will provide regulatory support to the cross-functional project teams.
Essential functions:

• Support development of regulatory CMC concepts and strategies for Immatics' cellular product candidates in the context of manufacturing process changes, method establishment and validation, tech transfer etc.
• Authoring and maintenance of CMC documentation for cellular products' INDs (Module 2.3 and 3) and EU CTAs (Q-IMPD, GMO documents, labels) in collaboration with international project teams in the U.S. and Europe.

• Authoring and support of responses to CMC requests for information by FDA and EU Competent Authorities.
• Supporting preparation of Health Authority meeting requests and meeting packages from regulatory CMC perspective.
• Processing and regulatory evaluation of change control procedures in the area of manufacturing.
• Research, analysis and Cross functional communication of regulatory requirements and information

Secondary functions:

• Development and review of SOPs and policies related to CMC Regulatory Affairs.

Competencies:

• A science degree (e.g., biology, chemistry, or pharmacy) or a master's degree in Regulatory Affairs is preferred.

Work environment:
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:

• Some travel is required -may require travelling domestically a few times per year or internationally once per year.

Required education and experience:

• A bachelor science degree (e.g., biology, chemistry or pharmacy) or a master's degree in Drug Regulatory Affairs
• Minimum of 4- years of experience in Regulatory Affairs CMC for gene and cellular therapies
• 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
• Strong verbal and written communication skills
• Strong knowledge of global regulations and GMP guidelines

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.