Responsible for the hands on regulatory activity required to submit, approve and launch new products
with minimal supervision.
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.
* 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
* 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
* Support and train associate team members
* 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
- competitive salary
- flexible working
- professional development
- career progression