Regulatory Affairs Lead

Newark, DE - USA

Yearly Salary: $ 90000 - 135000

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide If so we want to hear from you!

QPS Story:

Since its inception QPS has been assisting pharmaceutical biotechnology and medical device companies with their drug development efforts by providing a full range of DMPK Toxicology Bioanalysis Translational Medicine Early Phase Clinical and Phase II IV Clinical Research services. To meet the needs of our clients we strive to employ talented caring and committed individuals who will work collaboratively towards achieving our mission of improving human health and the quality of life.

Team members enjoy challenging and rewarding work and are encouraged achieve their best. Underpinning the operation is a culture that values diversity innovation accountability teamwork and a friendly atmosphere where performance is recognized and rewarded. We provide unique company benefits training and advancement opportunities. Most importantly we value each of our team members as employees and as individuals.

If this sounds like your ideal work environment then we would love to speak with you so apply today!

Please visit our website () for more information and to see all current openings.

The Job

As a Regulatory Affairs Lead with QPS (a full-service global Contract Research Organization) you will lead regulatory strategies and submission activities for sponsor clients across multiple therapeutic areas with a focus on U.S. FDA submissions. You will oversee regulatory deliverables collaborating with internal teams and sponsor stakeholders to ensure high-quality compliant submissions that meet all applicable health authority requirements.

Key Responsibilities:

Serveastheprimaryregulatoryleadonsponsorprojectsadvisingonandimplementingsubmission strategies for INDs NDAs amendments and other FDA-regulated filings.
Manageandcoordinatethepreparationreviewandtimelysubmissionofregulatorydocumentstothe FDA and other U.S. health authorities.
Participateinregulatoryauthoritymeetings(-INDTypeB/C)andassistsponsorswith briefing package development and logistical planning.
ProvideexpertguidancetointernalteamsandsponsorclientsonICHandFDAregulatory frameworks including CFR and GCP requirements.
Collaboratecross-functionallywithClinicalOperationsCMCPharmacovigilanceandMedicalWriting to ensure cohesive and high-quality submission content.
Maintainawarenessofchangesinregulatoryrequirementsandprovideproactivecommunicationand strategic recommendations to internal and external stakeholders.
Supportbusinessdevelopmentbycontributingtoproposalscapabilitiespresentationsandbid defense meetings requiring regulatory input.

Work Location

This job will be 100% home-office based. (see Telecommuting Policy for full details)

Requirements

Bachelors degree in life sciences pharmacy or a related field (advanced degree preferred).
58yearsofregulatoryaffairsexperiencewithatleast3yearsinaCROorclient-service environment.
Demonstrated experience with FDA regulatory submissions (e.g. IND NDA) in eCTD format.
Strong understanding of ICH GCP and FDA regulatory frameworks.
Excellentprojectmanagementandcommunicationskillswiththeabilitytomanagemultiplesponsor relationships and competing priorities.
Experience leading regulatory meetings with clients and/or FDA representatives.
Proficiencywithdocumentmanagementsystemsandsubmissionplatforms( GlobalSubmit or similar).
Regulatory Affairs Certification (RAC) or equivalent is a plus.

Preferred experience includes:

Exposure to oncology rare disease or biologics development programs.
Experience supporting early-phase clinical trials through to ( Therapy).
Ability to work effectively across time zones and in a fast-paced deadline-driven CRO environment.

Why You Should Apply

Great learning opportunities especially for those new to the field. Our seasoned professionals are here to support and work with you to explore your learning potential and career goals.
Structured Career Ladders that provide excellent growth based on your personal aspirations.
Bonuses and merit increases are a part of the QPS total rewards approach and are linked to individual team and company performance.
Solid Benefits package including Company-matched 401(k) and Company-sponsored Group Life/AD&D and Short and Long-term Disability Insurance
Park-like setting in Newark Delaware
Internal committees designed with the needs and enjoyment of QPS employees in mind.

QPS LLC is an Equal Employment Opportunity/Affirmative Action accordance with federal state and local laws we recruit hire promote and evaluate all personnel without regard to race color religion sex sexual orientation gender identity age national origin citizenship status physical disability protected veteran status or any other characteristic protected by law. Job applicants and present employees are evaluated solely on ability experience and the requirements of the addition QPS LLC is a federal contractor and desires priority referrals of protected veterans.

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Do you want to be part of an organization that is making a difference in the lives of millions of people worldwide If so we want to hear from you! QPS Story:Since its inception QPS has been assisting pharmaceutical biotechnology and medical device companies with their drug development efforts by pr...