Senior Regulatory Affairs Specialist

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
 

Division Information – Pharma Services Group (PSG)

The Greenville, NC site is a large, multipurpose pharmaceutical manufacturing and packaging campus supporting both clinical and commercial production. The facility specializes in solid dose and sterile manufacturing, including aseptic filling, lyophilization, biologics, small molecules, controlled substances, and secondary packaging. With advanced technical capabilities and a strong global regulatory inspection history, the site plays a critical role in delivering high-quality pharmaceutical products worldwide.

REQUIREMENTS:

• Bachelor's degree in a scientific or related field is required. Advanced Degree preferred. Preferred Fields of Study: Engineering, Life Sciences, Chemistry or related technical field

• 3-4 years of regulatory experience in the pharmaceutical industry strongly preferred

• Strong knowledge of cGMP, and applicable regulatory requirements (FDA, EMA, etc.)

• Expertise in quality systems including: CAPA and deviation management, change control, risk management and FMEA, document control, and internal/external auditing

• Excellent project management skills with ability to manage multiple projects simultaneously

• Strong analytical and problem-solving capabilities

• Clear written and verbal communication skills

• Experience working effectively in cross-functional team environments

• Fluency in English required; additional languages beneficial

• Proficiency with regulatory submissions software and Microsoft Office suite

• Experience with change control and post-market surveillance activities

• Strong attention to detail and organizational skills

• Ability to interpret and apply complex regulatory requirements

• Customer-focused mindset with business acumen

• Effective interpersonal skills and ability to build consensus

• Experience supporting regulatory staff development preferred

KNOWLEDGE, SKILLS, ABILITIES:

• Mature, results-oriented self-starter who can execute roles and responsibilities with minimal supervision.

• Ability to motivate and influence without line-management authority.

• Working knowledge of regional regulatory requirements and the global regulatory environment.

• Demonstrated ability to evaluate and resolve moderately complex regulatory and technical issues due to broad based knowledge of pharmaceutical manufacturing and related regulatory requirements.

• Strong organizational skills, with ability to multi-task in a fast-paced environment.

• Strong attention to technical detail.

• Highly effective verbal and written communication skills.

• Sound skills in typical office electronic platforms.

• Good negotiation and influencing skills with internal stakeholders, clients and regulatory bodies.

• Collaborative team player with strong interpersonal skills who fosters open communication and facilitates mutual understanding and cooperation between all stakeholders, internal and external.

• Ability to demonstrate discretion, confidentiality and independent judgement.

Relocation assistance is not provided.

Must be legally authorized to work in the United States now or in the future without sponsorship.

Must be able to pass a comprehensive background check, which includes a drug screening.

Equivalent combinations of education, training, and meaningful work experience may be considered.