Director of Global Regulatory Strategy - Remote EST

Orbis Clinical is seeking a remote-based Director of Global Regulatory Strategy for 9 months.

Job Title: Director of Global Regulatory Strategy

Location: Remote, must be able to work EST business hours

Contract: 9 months

Position:

Positively contributes to the global regulatory strategy for clinical therapeutic programs. Facilitate identification and resolution of scientific and regulatory issues with the regulatory agencies. Directs the preparation and submission of INDs, and CTAs for

clinical products. Remains current with evolving regulation and guidance for integrated review of guidance to develop strategies.

Primary Responsibilities Include:

Responsible for or contributes to proactively formulating regulatory strategies that provide a streamlined development and approval timeline while accurately interpreting and reflecting regulatory and corporate guidelines

Plans and manages integration of multi-disciplinary regulatory programs into the project team development plans for all assigned projects

Assists in representing the company at FDA and EMA agencies for all assigned products. Oversees the planning and conduct of meetings with regulatory agencies as appropriate

Assists Initiates and responds to regulatory agency contacts (telephone, written, meetings, etc.) to assure expedient and efficient review and approval of products

Ensures that all documents to be submitted to regulatory agencies have been evaluated to assure that they are complete, well organized, scientifically accurate, of high quality, are in regulatory compliance, and are presented in a way that facilitates agency review.

Guides project teams to implement appropriate regulatory strategies

Supervises and coordinates all regulatory activities required for submissions to regulatory agencies for assigned products

Contributes to, with the ability to own, SOPs and internal regulatory quality procedures

Impact and Scope

Works on complex issues where analysis of situations or data requires an in-depth knowledge of the company

Works on objectives that have critical impact on functional area and the organization

Erroneous decisions or failure to achieve results will add to costs, result in critical delay(s) and may have serious impact on the overall success of functional, division, or company operations

Desired Education and Skills:

Detailed knowledge of clinical and nonclinical data requirements for clinical studies

Demonstrated knowledge of drug development process

Knowledge of laws and regulations affecting the pharmaceutical industry, and regulatory experience

Experience with preparing regulatory submissions and briefing packages for regulatory meetings

Personal leadership, with an ability to bring divergent views together, agree on common objectives and engender enthusiasm even in challenging circumstances

Excellent interpersonal, collaboration, written, verbal and visual communication skills with ability to influence cross-functionally at all levels within the organization

Solid sense of accountability, sound judgement and decision-making skills, and strong attention to detail

Education and Experience

BS or equivalent with 12+ years of related experience

Prior regulatory affairs experience in major markets is expected

Compensation Details:

Orbis Clinical is an equal opportunity employer that provides a reasonable range of compensation for our positions. Actual compensation is influenced by a wide array of factors including, but not limited to, skill set, level of experience and specific office location.

The Pay Range for this position is $135.48 - $172.41 per hour, can vary depending on employment status.

Orbis Clinical offers eligible employees health benefits (medical, dental, and vision), employer-paid basic life and AD&D insurance, and a partial employer match on a 401(k).

EEO and Reasonable Accommodation Statement:

Stone Harbor Staffing Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, genetic information, veteran status, or any other characteristic protected by law. We also consider qualified applicants with criminal histories, consistent with applicable law. If you need assistance or an accommodation during the application process, please contact us.

By applying for this position, you agree that any calls from Orbis Clinical and its subsidiaries may be monitored or recorded for training and quality assurance purposes.