Senior Regulatory Affairs Associate

• 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 authority’s requirements and in compliance to local laws and regulations.

• 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.

• Independently execute variations for existing marketing authorisations to be submitted as per the relevant competent authority’s requirements and in compliance to local laws and regulations. Including the compilation of responses to authority questions within agreed timescales.

• Review and approved variations strategies & documentation prepared by other members of the regulatory team.

• 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 regulatory advice to support the business including change control SME.

• Review and approve internal documentation to ensure compliance for new or existing marketing authorisations (with minimal support), including marketing material.

• Develop and approve product information text in compliance with SOPs and relevant guidelines for variations.

• 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

•Undertakes such other reasonable duties as may be required from time to time to support the department and business activities.

• Acknowledge responsibility to ensure an effective Quality Management System in order to achieve Quality Objectives.

• 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 and variations in UK and EU.

 Knowledge globally would be beneficial.

• Basis understanding of bioequivalence guidelines

• Good CMC knowledge; eCTD publishing experience 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

• Typical Years of Experience- 2-4 years experience

• Minimum Expected Education- Level 6 – Bachelor’s Degree

• Additional Information- University Degree; Typically a minimum of 2 years work experience required

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