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Regulatory Affairs Assistant, Nordics

Descripción del puesto:

Want to think for yourself? As you'll have the freedom to forge a career as an expert in a niche, in-demand, business-critical role.

Driving innovation and protecting our customers, our Regulatory team is critical to ensure we keep up with complex legislation across multiple categories. Ultimately this allows us to continue making people's lives better.

Guaranteed pace and variety, you'll provide administrative and technical supporting to the Nordic Regulatory:
* Budget control / Commercial Fix Cost with close cooperation with the Nordics Reg & Med Manager
* Control and processing invoices in SAP / Creating POs / Keeping department budget tracker up-to-date, work in a close cooperation with the Finance teams
* Pre-clearance of artworks, promotional materials, PQR reports/PV reports
* Support Regulatory team with submissions for variations
* Keep various internal regulatory systems up-to-date (GRAIS,CARA etc.)
* Archiving of project correspondence, submission to authorities
* Collect listing documentation SE/FI/NO/DK
* Monitor authority webpages for RI
* Keep various local regulatory trackers up-to-date
* Process initiatives and projects in QualityOne system
* Handling documents from Global Databases
* Administrative support in regulatory SOP development
* Act as a link between the Consumer Relations (CR) Hub and the Nordic Reg/Med team
* Support in on- and offboarding of team members and introduction program

Qualifications:

Education: Successfully completed technical education (e.g. CTA, BTA, PTA, Chemialaborant, Biologielaborant or similar education)
Experience: Good understanding of the relevant processes in Regulatory & medical affairs, Quality management and Pharmacovigilance / Basic medical understanding required to be technically and legally qualified to respond to requests for medical information
Language skills: Fluency in English and one of Nordic languages (both oral and written)

Other requirements:
* Strong administrative skills
* Strong organizational skills
* Strong computer system skills
* Hands-on-mentality

You'll succeed because…
…you are comfortable working in a scientific environment. Keen to develop your expertise and build a career in a leading global business, you:
* Have close attention to detail and are comfortable reviewing and documenting technical information
* Have excellent oral and written communication skills
* Maintain high standards for quality, even under tight time constraints
* Are results-orientated and able to juggle multiple projects and priorities.

You'll love it because…
…you'll have the freedom to make a difference. You'll put your own ideas into practice. The products you get out there will allow people to live healthier lives and have happier homes. And our dynamic, ownership-driven culture will bring the very best out of you, every day.

Interested?
* Please apply through the link with your CV and motivational letter.
* If any questions regarding the position, please contact Axxxxxxxxx.xxxxxxxx@xx.xxm

Equality

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law

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Regulatory Affairs Assistant, Nordics

Descripción del puesto:

Want to think for yourself? As you'll have the freedom to forge a career as an expert in a niche, in-demand, business-critical role.

Driving innovation and protecting our customers, our Regulatory team is critical to ensure we keep up with complex legislation across multiple categories. Ultimately this allows us to continue making people's lives better.

Guaranteed pace and variety, you'll provide administrative and technical supporting to the Nordic Regulatory:
* Budget control / Commercial Fix Cost with close cooperation with the Nordics Reg & Med Manager
* Control and processing invoices in SAP / Creating POs / Keeping department budget tracker up-to-date, work in a close cooperation with the Finance teams
* Pre-clearance of artworks, promotional materials, PQR reports/PV reports
* Support Regulatory team with submissions for variations
* Keep various internal regulatory systems up-to-date (GRAIS,CARA etc.)
* Archiving of project correspondence, submission to authorities
* Collect listing documentation SE/FI/NO/DK
* Monitor authority webpages for RI
* Keep various local regulatory trackers up-to-date
* Process initiatives and projects in QualityOne system
* Handling documents from Global Databases
* Administrative support in regulatory SOP development
* Act as a link between the Consumer Relations (CR) Hub and the Nordic Reg/Med team
* Support in on- and offboarding of team members and introduction program

Qualifications:

Education: Successfully completed technical education (e.g. CTA, BTA, PTA, Chemialaborant, Biologielaborant or similar education)
Experience: Good understanding of the relevant processes in Regulatory & medical affairs, Quality management and Pharmacovigilance / Basic medical understanding required to be technically and legally qualified to respond to requests for medical information
Language skills: Fluency in English and one of Nordic languages (both oral and written)

Other requirements:
* Strong administrative skills
* Strong organizational skills
* Strong computer system skills
* Hands-on-mentality

You'll succeed because…
…you are comfortable working in a scientific environment. Keen to develop your expertise and build a career in a leading global business, you:
* Have close attention to detail and are comfortable reviewing and documenting technical information
* Have excellent oral and written communication skills
* Maintain high standards for quality, even under tight time constraints
* Are results-orientated and able to juggle multiple projects and priorities.

You'll love it because…
…you'll have the freedom to make a difference. You'll put your own ideas into practice. The products you get out there will allow people to live healthier lives and have happier homes. And our dynamic, ownership-driven culture will bring the very best out of you, every day.

Interested?
* Please apply through the link with your CV and motivational letter.
* If any questions regarding the position, please contact Axxxxxxxxx.xxxxxxxx@xx.xxm

Equality

All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law

Skriv i din ansøgning, at du fandt jobbet på ofir.dk


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Modtag jobannoncer der minder om dette job i din indbakke.




Når du tilmelder dig accepterer du samtidig vores privatlivspolitik. Du kan altid trække dit samtykke tilbage.

Andre job der minder om dette

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17. maj 2022

Product Quality Lead, Biologics

lundbeck A/S

København K
Product Quality Lead, Biologics Join our community of specialists and take part in the journey towards restoring brain health You have a unique opportunity to join our CMC Biologics team as a Product Quality Lead where you will provide technical ...
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Descripción del puesto: Do you want to use your strong quality mind-set and great interpersonal skills to make a difference within QA? Are you eager to play an important role in ensuring the quality and safety of products for clinical trials? If so...
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