Regulatory Affairs Senior Specialist/Manager

Regulatory Affairs Senior Specialist/Manager


ESSENTIAL FUNCTIONS
  • 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.
POSITION QUALIFICATIONS
  • 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
Education:
  • 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
Experience:
  • Five plus years of experience with regulatory affairs within pharmaceutical clinical research
Computer Skills:
  • 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.
Other Requirements:
  • 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%

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Skills

Posted on

September 20, 2022