Description

Position at Kymanox
Is Kymanox the right fit for you?
You want to make a difference and have an impact...
You enjoy having an influence in your day to day work...
You are motivated by working alongside a team filled with
subject matter experts that will help you learn and grow...
You wake up every day and do what you do
because patients deserve better.
If this sounds like you, you've come to the right place.
Kymanox is hiring a Principal Consultant, Regulatory Affairs (Contractor) that will help lead regulatory service projects by providing robust regulatory strategies, leading interactions with regulatory agencies, and preparing regulatory submissions covering drug products, biologics, and combination products. This position involves high-level strategic planning as well as hands-on responsibilities. Services may be provided at a client site, from a Kymanox office, or remotely.
Primary Responsibilities:

• Develops regulatory strategy and guides US and EU regulatory submissions (IND/NDA/BLA/ MAA/IMPD), meeting information packages, clinical trial applications, and other submissions for regulatory authorities.
• Leads and/or attends meetings with regulatory authorities.
• Performs regulatory review of source documents. Generates regulatory assessments that guide regulatory strategy to support the project team and inform client decisions.
• Reviews and edits dossiers, briefing books, and responses to health authority questions; works with SMEs and authors to prepare information for submissions and ensure submission readiness.
• Conducts gap assessments of regulatory submissions, clinical data, nonclinical data, against industry regulations and standards (US/EU/ROW).
• Identifies and interprets regulations, guidelines, and other pertinent information issued by applicable regulatory agencies and other regulatory organizations.
• Manages regulatory submission timelines in accordance with client expectations and regulatory authority requirements. Informs clients of regulatory risks.
• Provides assessment of regulatory impact of changes to approved products.

Minimum Qualifications:

• Master's degree or higher in Regulatory Affairs or science discipline.
• 5 years' regulatory experience in the US pharmaceutical or biopharmaceutical products industry.
• Demonstrated experience of preparing US FDA/EU EMA submissions (eg, IND/NDA/ BLA/MAA/IMPD), including eCTD sections (specifically Module 2 or integrated summary of safety and/or efficacy).
• Experience performing literature research and reviews.
• Working knowledge of FDA guidance and ICH guidelines for CTD, clinical, nonclinical and pharmaceutical quality requirements.

About Kymanox:
Kymanox ('ki-mah-noks'), meaning Ideal Knowledge Transfer, advances life science innovation through insightful solutions and collaboration. We do this by accelerating the design and commercialization of modern medicines for our customers using integrated engineering, scientific, compliance, and project management solutions that are insightful, collaborative, and comprehensive.
By building and supporting the development of modern medicines, Kymanox has proven, end-to-end solutions that are helping bring better Life Science Products to the market- and keep it there. We do all of this with heart and pride because patients deserve better.
Kymanox, founded in 2004, serves clients from Fortune 100 companies to virtual start-up companies all across the globe. Headquartered in Research Triangle Park, NC, we have US offices in Boston and Philadelphia, and since 2022 have expanded to Germany, Switzerland, and Israel.
Kymanox is an equal-opportunity employer and works diligently to protect the rights of job seekers by following all local, state, and federal laws as well as best Human Resource (HR) practices in the Life Science industry.