Clinical Regulatory Associate
This Clinical Regulatory Associate role plays a vital part in our global regulatory team, responsible for developing and executing US and Canada regulatory strategies. The ideal candidate will possess strong regulatory knowledge, excellent communication skills, and be able to work effectively in a team environment.
Main Responsibilities:
* Regulatory Strategy Creation: Create comprehensive regulatory strategies by analyzing regulatory trends, scientific knowledge, and competitor labelling information.
* Regulator Feedback Analysis: Analyze and summarize regulator feedback to inform regulatory strategies.
* Competitor Product Monitoring: Monitor recent and upcoming approvals of competitor products.
* Clear Communication: Communicate key information to facilitate smooth execution of regulatory strategies.
* Regulatory Option Evaluation: Evaluate regulatory options and their potential impact on product development plans.
* Regulatory Innovation: Develop innovative regulatory strategies to accelerate product development while differentiating our offerings.
* Labelling Document Development: Contribute to the creation of high-quality labelling documents for regulatory submissions.
* Regulatory Discussions: Engage in strategic discussions with stakeholders to align on regulatory approaches.
* Regulatory Submission Guidance: Provide guidance on regulatory submission requirements and expectations.
* Regulatory Document Preparation: Prepare regulatory documents for submissions.
* Regulatory Challenges: Develop creative solutions to address regulatory challenges.
* Regulatory Advisory Services: Offer high-quality, timely regulatory advice to support informed decision-making.
* Regulatory Risk Management: Identify and mitigate regulatory risks to ensure compliance and business success.
* Collaboration and Communication: Foster effective collaboration and communication with stakeholders to ensure mutual understanding.
Essential Qualifications:
* Bachelor's degree in a relevant scientific or health science field.
* PREFERRED: 2+ years of experience in regulatory affairs or drug development.
* Familiarity with FDA and Health Canada procedures and practices desirable.
* Deep understanding of the drug development process, regulatory strategies, and plans.
* Ability to assess and manage risk in a complex regulatory environment.
* Excellent written, verbal, and presentation communication skills.
* Negotiation and influence skills.
* Meticulous attention to detail.
* Effective teamwork and interpersonal skills.