The Regulatory Affairs Manager will support regulatory activities of our organization to ensure compliance with domestic and international regulations and standard operating procedures. This individual must demonstrate effective teamwork by developing collaborative relationships with internal and external personnel, as well as through highly effective oral and written communication skills.
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
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%
Lumos Pharma is a clinical-stage biopharmaceutical company whose mission is to develop new therapies for people with rare diseases, prioritizing its focus where the medical need is high, and the pathophysiology is clear. We are committed to this mission and a strategy that is grounded upon time and cost-efficient drug development to deliver safe and effective therapies to patients.