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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.

Location/Division Specific Information

Remote, Canada; Remote, Illinois, USA; Remote, Massachusetts, USA; Remote, Pennsylvania, USA

This position is a Senior Manager role and will be based remotely in the USA or Canada. It will provide customer-facing regulatory services to support the Pharma Services Group within Thermo Fisher Scientific.

How will you make an impact?

Reporting to the Director, Regulatory Affairs, the Sr Manager will plan, coordinate, and provide Regulatory Services activities supporting Regulatory Chemistry, Manufacturing and Controls (CMC) aspects of customer projects in accordance with the Regulatory Services menu, including project quote development.

What will you do?

• Author, review, and provide comments for Chemistry Manufacturing and Control (CMC) CTD documents for small molecule/oral dosage form products and active pharmaceutical ingredients (APIs), including Investigational Applications (IND, IMPD, CTA), Marketing Applications (NDA, ANDA, MAA), and post-approval lifecycle dossiers, gap analyses and responses to Health Authority review questions per the Regulatory Affairs Services Menu.
• Collaborate and coordinate with technical experts to support the compilation of Regulatory CMC CTD documents.
• Provide strategic regulatory support for the oral solid dosage form and API manufacturing sites and their customers.
• Conduct gap analysis of regulatory documents and provide remediation strategies.
• Develop quotes for regulatory services.
• Support key company projects such as new facilities and new strategic customers.
• Track Regulatory Services metrics for Regulatory CMC OSD projects, and assist with collation and reporting out for the Regulatory network.
• Participate in regulatory intelligence surveillance and communication to the network.

Apply now at:  https://jobs.thermofisher.com/global/en/job/R-01199115/Sr-Manager-Regulatory-Affairs-CMC

Education

• Bachelor’s degree in a scientific, or related field is required.

Experience

• 7-9 years regulatory experience in the pharmaceutical industry with a focus on Regulatory CMC for small molecules.

• Consulting/customer-facing regulatory services experience is an asset.

Knowledge, Skills, Abilities

• Self-starter who can carry out roles and responsibilities with minimal direction.
• Solid understanding of the global regulatory environment for small molecule/OSD drugs.
• Ability to evaluate and resolve complex regulatory and technical issues due to extensive knowledge of pharmaceutical manufacturing and related regulatory requirements in this product sector.
• Strong collaborator with excellent interpersonal skills who cultivates open communication and facilitates mutual understanding and cooperation between all stakeholders, internal and external.
• Negotiating and influencing skills with management levels of internal stakeholders and customers, and with regulatory bodies is required, aided by the ability to demonstrate discretion, confidentiality and independent judgement.
• Effective time management and prioritization skills, with ability to multi-task in a fast-paced environment, excellent attention to technical detail and highly effective verbal and written communication skills.
• Sound skills in typical office electronic platforms.