Principal Regulatory Affairs Associate ( 12 Month FTC)

 

Major Duties and Responsibilities

• Develop strategies to support new product development with support from line manager

• Independently 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 as per the relevant competent authorities requirements and in

compliance to local laws and regulations.

• Leading and negotiating for regulatory affairs in meetings with internal & external stakeholders,

working cross functionally to achieve the business goal. As a product owner, independently

providing comprehensive and detailed regulatory advice to support the business including change

control SME.

• Identify risks to the submission, propose mitigating strategies and independently negotiate directly

with health authorities to resolve regulatory issues.

• Review and approved on documentation prepared by internal & external stakeholders,

independently using regulatory knowledge and guidelines to ensure compliance for new

marketing authorisations, including marketing materials.

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

Guiding other team members.

• Ensure regulatory files and data systems are maintained in compliance with SOPs and KPIs in

line with business goals. Support continuous improvements to regulatory and business

processes.

• Approve product information text in compliance with SOPs and relevant guidelines.

• Train and mentor 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.

Competencies

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

• Understanding of the workings of global competent authorities.

• Excellent understanding of regulatory legal basis licensing requirements in particular generic

submissions

• Good understanding of bioequivalence guidelines

• Detailed CMC knowledge; eCTD beneficial

• Shows initiative and drive, particular when faced with a problem

• Demonstrates good planning and prioritisation abilities across projects with flexibility and agility

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

• MS-Office knowledge essential

Knowledge and Experience

• Typical Years of- 4-6 years experience

•Minimum Expected-Level 6 – Bachelor’s

•Additional Information-University Degree in Life Science; Typically a

minimum of 4 years work experience required