Find job

Regulatory Affairs Associate

Company description:

PRA As a top five CRO, we have worked on 100+ marketed drugs across several therapeutic areas and conducted the pivotal or supportive trials that led to FDA and/or international regulatory approval of 45+ such drugs. At PRA Health Sciences, providing innovative solutions for our clients is what we do. From full service clinical development to the pioneering Embedded SolutionsTM model, PRA provides a broad spectrum of solutions that meet the demands of a diverse marketplace. At PRA, borders do not create boundaries. PRA's success is dependent upon our ability to attract and retain a talented team of diverse professionals. Our growing workforce is comprised of over 10,000 employees, spanning 13 time zones across six continents and who speak more than 30 languages - yet operate in unison as one worldwide PRA community.

Job description:

PRA are seeking to hire an experienced Regulatory Affairs professional with the ability to develop into a Line Manager within the Regulatory Affairs business unit. The Regulatory Affairs Associate (RAA) is responsible for preparing, submitting and following up on initial and amended Ministry of Health (MoH), Central Independent Ethics Committee (IEC), and any other central submissions required in the country(s) you will be responsible for within contracted timelines and budget, in accordance with local regulatory requirements and sound scientific/technical principles, including the creation and modification of documentation required for approval. The RAA is responsible for ensuring that all importation and exportation requirements are met for Investigational Product and any other clinical trial supplies needed for the trial within their country.

The RAA is also responsible for providing review of the translation into the local language of clinical trial supply labeling to ensure it meets local regulatory requirements. Additionally the RAA will ensure that Insurance Certificates, Country Specific Informed Consent forms and any other patient documentation adheres to country requirements. The Regulatory Affairs Associate (RAA) is responsible for preparing, submitting and following up on initial and amended Ministry of Health (MoH), Central Independent Ethics Committee (IEC), and any other central submissions required in the country(s) you will be responsible for within contracted timelines and budget, in accordance with local regulatory requirements and sound scientific/technical principles, including the creation and modification of documentation required for approval. The RAA is responsible for ensuring that all importation and exportation requirements are met for Investigational Product and any other clinical trial supplies needed for the trial within their country. The RAA is also responsible for providing review of the translation into the local language of clinical trial supply labeling to ensure it meets local regulatory requirements. Additionally the RAA will ensure that Insurance Certificates, Country Specific Informed Consent forms and any other patient documentation adheres to country requirements.

Required profile:

To be considered for the Regulatory Affairs Associate position you must have a BA/BSc (or equivalent) in a related science field along with some experience working within regulatory affairs within either a pharma or CRO. Experience of Regulatory submissions is essential. You must be fluent in English, and at least one Nordic language.

What we offer:

Competitive Salary and benefits

Apply online Gem job

Arbejdssted

Lund

Cookies på StepStone

Vi bruger cookies til trafikmåling og til optimering af hjemmesidens indhold. Der gemmes cookies fra StepStone og fra vores samarbejdspartnere. Ved at klikke videre på hjemmesiden accepterer du vores brug af cookies. Læs mere om vores cookies.