Regulatory Affairs Specialist III

Work Schedule

Environmental Conditions

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.

SUMMARY :

As a Regulatory Affairs Specialist III, you will provide Regulatory Services activities supporting regulatory aspects of customer projects in accordance with the Regulatory Services menu. Execute activities and collaborate to assure the company/site compliance with applicable regulations including establishment registration, drug listing, drug master files and site master files. NOTE: We are not able to offer relocation assistance or visa sponsorship for this role at this time

RESPONSIBILITIES:

• Contribute to authoring, review and provide comments for Chemistry Manufacturing and Control (CMC) CTD documents, including Investigational Applications (IND, CTX), Marketing Applications (NDA, NDS, MAA, BLA), and post-approval lifecycle dossiers, per the North American Regulatory Affairs Services Menu

• Collaborate and coordinate with SMEs to support the authoring and review activities of CMC CTD documents

• Prepare company regulatory submissions (e.g. site master files, drug master files)

• Support key company projects in the North America region such as new facilities, new strategic customers

• Contribute to moderately complex regulatory strategic advice for internal customers and clients

• Contribute to the maintenance of centralized records for compliance status of North American manufacturing sites

• Participate in regulatory impact evaluation of change controls

• Track NA Regulatory Services metrics for self-assist with collation and reporting out for North American network

• Contribute to regulatory intelligence surveillance and communication to the network

• 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

• ASQ certifications (CQE, CQA) desired

• Strong knowledge of cGMP, ISO 13485/9001, 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

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.