- Assist with the preparation and submission of regulatory agency applications, reports, or correspondence.
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards.
- Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
- Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
- Assist with managing activities such as audits, regulatory agency inspections, or product recalls.
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Provide responses to regulatory agencies regarding product information or issues.
- Maintain current knowledge of relevant regulations, including proposed and final rules.
- Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
- Represent organizations before domestic or international regulatory agencies on major policy matters or decisions regarding company products.
- Oversee documentation efforts to ensure compliance with domestic and international regulations and standards.
- Participate in the development of clinical trial protocols.
- Develop and maintain standard operating procedures or local working practices.
- Establish regulatory priorities or budgets and allocate resources and workloads.
- Train staff in regulatory policies or procedures.
- Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
- Maintain procedures or systems for publishing document submissions either in hardcopy or electronic formats.
- Contribute to the development or implementation of business unit strategic and operating plans.
- Coordinate internal discoveries and depositions with legal department staff.
- Evaluate new software publishing systems
- Monitor new trends or updates related to electronic publishing of submissions.
- Review, edit and approve SOPs and other applicable quality systems documents.
- Develop relationships with state or federal environmental regulatory agencies to learn about and analyze the potential impacts of proposed environmental policy regulations.
- Analytical Skills – Analytical skills look at the ability of the individual to gather raw data and to process that data into a meaningful form.
- Applied Learning – Ability to participate in needed learning activities in a way that makes the most of the learning experience.
- Business Acumen – Business acumen looks at the ability of the individual to understand and discriminate between various business-related topics and issues.
- Coaching and Development – Ability to provide guidance and feedback to help others strengthen specific knowledge/skill areas.
- Communication – Communication skills look at the extent to which an individual communicates with economy and clarity in both written and verbal forms; clearly understand others’ message and intent and receives and processes feedback.
- Decision Making/Judgment – Decision making skills look at the ability of the individual to select an effective course of action while controlling resources and expenditures.
- Detail Oriented – Ability to pay attention to the minute details of a project or task.
- Ethical – Ability to demonstrate conduct conforming to a set of values and accepted standards.
- Goal Oriented – Ability to focus on a goal and obtain a pre-determined result.
- Innovative – Innovation is the ability to go beyond the conventional, a willingness to try different solutions, and to encourage innovative ideas from employees and co-workers.
- Management Skills – Managerial skills look at the ability of the individual to achieve desired outcomes by setting goals and priorities that deliver results.
- Project Management – Ability to organize and direct a project to completion.
- Relationship Building – Relationship building looks at the ability of the individual to establish and maintain a good rapport and cooperative relationship with customers and co-workers.
SKILLS & ABILITIES
- Bachelor’s Degree (four-year college or technical school): Required
- Degree in a healthcare related field or the life science is desirable: or Work Equivalent
- Five plus years of experience with regulatory affairs within pharmaceutical clinical research
- Must be proficient in Microsoft Word, Microsoft Excel, Microsoft PowerPoint, and other Microsoft applications; familiarity with EDC systems required.
- Must be proficient with eCTD submission development and the use of publishing tools.
- Excellent organizational, leadership and critical thinking skills
- Willing and capable to manage multiple projects, negotiate budgets, timelines, and responsibilities
- Must be willing to travel as required for the project- estimated travel ~10%