Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at raps@raps.org if you need assistance.
E-mail address & Password Combo is invalid
- News
- Membership
- Education
- Certification
- Resources
-
Member Knowledge Center
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
Get Started
-
NEW! RAC Spotlights
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
LEARN MORE
Home > Career Center
Loading...
Job Seekers, Welcome to Regulatory Career Connections
Active Advanced Search Filters: (Click to remove)
Search Filters
Use this area to filter your search results. Each filter option allows for multiple selections.
NEW! NEW!
NEW! NEW!
NEW! NEW!
Meridian Bioscience
Cincinnati, Ohio
Sumitomo Pharma Oncology Inc
Malborough, Massachusetts
Featured! Featured!
United Therapeutics Corporation
Manchester, New Hampshire
The University of Vermont Medical Center
Burlington, Vermont
NEW! NEW!
Loading... Please wait.
Application
Details
Posted: 25-Jul-22
Location: Ames, Iowa
Type: Full Time
Required Education: 4 Year Degree
Categories:
Quality/Risk Management
Preferred Education:
4 Year Degree
Additional Information:
Telecommuting is allowed.
Internal Number: 399
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.
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
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%
About Lumos Pharma, Inc.
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.
More Jobs from This Employer
https://regulatorycareers.raps.org/jobs/17168568/regulatory-affairs-manager
Loading. Please wait.
Error
Powered By
For assistance please call 888.491.8833 or e-mail candidatesupport@naylor.com