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.
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.
How will you get here?
Education
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.
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, and a range of employee benefits! Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 100,000+ colleagues, we share a common set of values, working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.
This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
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