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Project Execution & Success
-Providing a full range of consulting services within personal area of expertise dealing mainly in areas where policy or precedent is clear.
-Facilitating client decision making by framing issues, presenting options and proving
objective business advice.
-Acting as an advisor to clients and project team on technical and/ or process issues.
-Leveraging senior colleagues to discuss possible problems or conflicts. Seeks guidance
periodically on appropriate methods of executing the plan.
-Developing business solutions addressing specific client needs using best practices and
knowledge of the client's business and key industry drivers.
-Assisting with presentations and preparation of proposals.
-Proactive in assessing client needs and developing processes and solutions to address issues before they become significant problems.
-Alerting to and identifying opportunities for follow-on business.
-Contributing information to support the account planning process and integrated marketing programs.
-May manage small projects and will be perceived as assisting in the management of larger projects.
-Demonstrating follow through and appreciation for project deadlines to meet project
objectives.
-Capitalizing on opportunities to improve project efficiency, results or team performance and proactively takes action.
-Using information from previous projects or other work with the client to make business
decisions.
Specific
-Preparing regulatory strategy documents for clients, based on detailed analysis of technical/scientific documentation and current knowledge of applicable regulations
-Jointly with Regulatory Operations staff, responsible for design and completion of regulatory submissions (clinical trial applications, marketing applications, others for assigned projects; interface with clients as appropriate while preparing submissions.
-Maintaining current knowledge of applicable regulatory requirements in the disciplines and territories relevant to the assigned client projects, and advise clients accordingly.
Maintaining appropriate liaison with regulatory authorities.
-Conducting critical reviews of key scientific documents in submissions, aiming to ensure completeness, fairness, scientific accuracy, ease of review.
-Regulatory project management: functioning as Project Manager on assigned projects, coordinating and managing flow of information, document client contact, track project progress, identifying and solving problems in a team-oriented environment.
-Assuring communication among appropriate Company technical resources (regardless of location) as related to assigned client projects, and maintaining focus on the deliverables premised in agreements for services.
-Providing guidance to assigned staff to assure quality, accuracy, completeness of deliverables.
Essential Skills & Capabilities:
Education
-Bachelor's or Master's degree in a scientific/technical discipline, ideally Chemistry or Pharmacology/Toxicology; Doctoral degree preferred.
Minimum Work Experience
-Experience in regulatory affairs and submissions, preferably multinational, in a
pharmaceutical or biotechnology industry environment; Chemistry, Manufacturing and Controls or Pharmacology/Toxicology experience preferred.
Skills
General
-Demonstrated team leadership skills
-Ability to interact at multiple levels within a client organization.
-Demonstrated ability to prioritize work and define steps needed to achieve specified project outcomes.
-Excellent written and verbal communication skills
-Significant travel may be required as client needs dictate
Specific
-Demonstrated ability to interact effectively with regulatory authorities and industry clients/colleagues on highly technical matters for purposes of preparing high-quality, successful regulatory documents and submissions.
-Foreign languages a plus
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