Regulatory affairs senior associate, licensing - united kingdom, united kingdom

responsible for the hands on regulatory activity required to submit, approve and launch new products

with minimal supervision.

client details

a leading developer, reliable manufacturer and global supplier of novel-delivery, patient-focused medicines with a portfolio of oral liquid medicines across a range of therapeutic areas.

description

assist in execution of regulatory activities per the project plan to assure new products meet

submission, approval and commercial launch goals. including management of applications for new

marketing authorisations (with minimal supervision) as per the relevant competent authorities

requirements and in compliance to local laws and regulations.

review and approved variations strategies & documentation prepared by other members of the

regulatory team.

identify risks to the submission, engaging in proactive discussion with line manager, health authorities

or other stakeholders to resolve any regulatory issues related to new marketing authorisations.

related to new project development projects: active participation as regulatory affairs representative

in meetings with internal & external stakeholders, working cross functionally to achieve the business

goal. as a product owner, providing comprehensive and detailed regulatory advice to support the

business including change control sme.

related to new project development projects: review and approve internal documentation to ensure

compliance for new marketing authorisations (with minimal support), including marketing material.

develop and approve product information text in compliance with sops and relevant guidelines for

new marketing authorisation.

maintenance regulatory systems and provide timely notification to internal & external stakeholders in

line with kpis to ensure compliance to the marketing authorisation and supporting product launch

goal.

support and train associate team members

profile

current awareness of legal framework and forthcoming legislation that may affect the business

understanding of the workings of global competent authorities.

good understanding of regulatory legal basis licensing requirements in particular generic submissions

basis understanding of bioequivalence guidelines

good cmc knowledge; ectd beneficial

shows initiative and drive, particular when faced with a problem

demonstrates good planning abilities with flexibility and agility

excellent written and verbal communication skills essential, including good attention to detail

ms-office knowledge essential

job offer

- competitive salary

- flexible working

- professional development

- career progression


Michael Page
United Kingdom, United Kingdom
2022-08-19
2022-09-18
FULL-TIME
1918916
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