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Form of workApply Job no: 43878 Category: Regulatory Affairs Job Description Our client, a leading pharmaceutical company, is currently recruiting a Director of Regulatory Affairs who will infuse the Regulatory Affairs Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative and growth-oriented vision. Responsibilities include: 1) Evaluate potential pipeline assets and FDA-approved product acquisition targets of strategic interest to the company 2) Identify the need for new regulatory policies, processes and SOPs and approve them 3) Set quality and accuracy standards 4) Evaluate the regulatory pathway for potential pipeline assets, considering the necessary clinical and regulatory requirements needed for FDA approval and other regulatory activities 5) Understand integrated data from clinical trials, including but not limited to efficacy, safety, pharmacovigilance and clinical pharmacokinetics 6) Generate assessment of competitive drug product regulatory and clinical critical approval factors 7) Assess the current regulatory pathways within relevant therapeutic areas to provide insight on potential future investments needed to build the scientific platform for potential pipeline or product acquisition targets 8) Prepare and present briefs of research data and findings to the company Executive and Senior Leadership to gain alignment on proposed action with potential drug products 9) Perform other duties as assigned Critical Requirements 1) A university degree is required.
Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field 2) Appropriate full-time work experience is mandatory (no students or fresh graduates please) 3) Recent experience in the pharmaceutical industry is strongly preferred 4) Preference will be given to candidates with recent experience in Regulatory Affairs management For the right leader, this is a wonderfully rewarding role with tremendous growth prospects. If you are qualified and think you're a strong fit for this role, please apply ASAP. We thank all applicants, but only candidates who meet our client's criteria will be contacted.
Compensation and Other Details Base Salary: Highly competitive package, commensurate with experience Published on 15 Mar 2023, 4:52 PM
