Director Of Regulatory Affairs Jobs in Colorado

Job Title: Regulatory Affairs Mgr Company: AMGEN Location: Longmont, CO Description: This is an opportunity for a Manager position in the CMC group within Amgen s Regulatory Affairs department. The CMC group facilitates product development and global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle. Key responsibilities include Responsible for site RA CMC activities, including change control, ARMC/AR/APR, regulatory review of site documents, inspection support, data integrity of regulatory submissions, facility registration documents, non conformance assessments, projects. Responsible for representing site on CMC product teams; communication site considerations, concerns, strategies and timelines; leading or supporting regulatory filings and/or sections authored by functional areas at the site Contributes to the strategy of CMC product timelines Provide cross-product regulatory expertise, oversight, and guidance Accountable for interactions with authors and reviews for regulatory CMC submissions Contributes to CMC product teams: Reports cross-product concerns and constraints to teams, site and department Provide regulatory CMC support for in-licensing and out-licensing activities Provides regulatory assessments of change control requests May be responsible for training staff on select CMC procedures and systems Provide expertise and guidance on teams for interdepartmental and cross-functional teams including, process improvement standards development, and metrics Contributes to CMC product teams: interacts with authors/reviewers to with respect the conformance of the documents to regulatory and CMC department requirements May participate in cross-functional special project teams CMC meetings with agencies: Contributes to the decision to request meeting, regulatory strategy & risk analysis; briefing document; key messages; May draft meeting minutes. Contributes to CMC departments: contributes to the design and content development of department training programs; participates in development and modification of procedures and training materials. Monitor and assess impact of global regulations, guidance's, and current regulatory environment and apply to job; educate Amgen stakeholders Contributes comments to Regulatory guidance documents Provide expertise and guidance on teams for interdepartmental and cross-functional teams including, process improvement standards development, and metrics Regulatory intelligence updates, compliance gap assessments Contributes to Global Regulatory and Operations Teams to establish global registration and labeling strategies; represent regional, site and/or functional activity; contribute to Global regulatory plan; contributes to global regulatory position Represent Amgen on trade associations Assist corporate training on regulatory affairs and contribute to the design and content development of department training programs Advocate and actively support regulatory/safety compliance Basic Qualifications BS - life sciences, engineering or related field Preferred Qualifications MS, or higher, - life sciences, engineering or related field 7-10 years related experience in pharmaceutical/biotechnology or medical device industry; 5+ years experience in Regulatory Affairs

Job Title: Manager, Regulatory Affairs (Natural Gas Utility) Company: SourceGas Location: Denver, CO Description: Manage analysis and support for the regulated natural gas distribution pipeline business. Energy,Re-energized. Headquartered just outside of Denver in the community of Lakewood, SourceGas is a leading supplier and distributor of natural gas to residential and business customers in Arkansas, Colorado, Nebraska, and Wyoming. And it’s no secret that our steady growth has been fueled by the talent and energy of our dedicated employee base. That same growth has now created the following opportunity to join our close-knit corporate headquarters team. Manager, Regulatory Affairs- 1267 Lakewood, CO Job Responsibilities Manage analysis and support for the regulated natural gas distribution pipeline business. Use FERC account data to support regulatory filings. Prepares, oversees and reviews analyses, documents, exhibits and other studies for rate case filings, gas cost adjustments, rate and tariff analyses and other requests. Also works with tariff changes and new service proposals to allow business segments to remain competitive and operate with flexibility, while staying in compliance with regulations. Primary responsibility is to assemble and support the accounting data necessary for regulatory filings Sponsor the revenue requirement model Interface with the finance department at multiple levels Manage analytical support on rate and tariff-related matters for the regulated natural gas distribution business Manage regulatory support to the distribution business unit leaders related to day-to-day operations Gather and compile the necessary information, analyses, and exhibits to complete timely filings with regulatory agencies Coordinate and/or perform the compilation of cost-revenue studies and financial analyses related to the earnings of the regulated distribution business and for internal financial reporting Keep abreast of, interpret, and communicate applicable regulatory agency regulations and statutes with internal departments and ensure compliance with those policies Support budgeting and financial forecasting and reporting Provide analytical and regulatory support to teams studying potential acquisitions Represent the Company in regulatory hearings, trade association meetings and in negotiation with commission staffs Provide supervisory duties (as related to work direction, not employment actions) Write effectively and understand written communications, including but not limited to email Develop and maintain a positive working relationship between with internal and external customers, and departments supported Deal with a wide variety of people with tact, courtesy and professionalism Speak clearly, both in person and by telephone, using a high level of verbal skills, and listen carefully Maintain a regular, dependable attendance, and high level of performance Maintain a high regard for personal safety, the safety of company assets and employees, and the general public Other daily, weekly and monthly duties or special projects as assigned May be required to work non-traditional hours May be required to carry a company-provided cell phone/pager and be available to respond during working hours; may be required to respond during non-working hours Travel within a geographic region (generally Colorado, Wyoming, Nebraska and Arkansas as of January 2010), and occasionally out of the geographic region, may be required and is anticipated, including overnight and/or weekend travel Educational Requirements Undergraduate degree from an accredited institution in Accounting, Finance, Economics, Engineering, Business or related field Education in technical areas of utility regulation, engineering or natural gas utility is desirable Job Requirements In addition to the degree requirement, must have experience with the use of FERC Uniform System of Accounts data in regulatory filings, and as a witness in a utility rate and/or regulatory proceeding. A minimum of ten years direct work experience with utility accounting, rates, and tariffs in a natural gas regulatory environment is required; should include but is not limited to working with gas cost adjustments and/or cost of service Intermediate to advanced proficiency level in Microsoft applications, including but not limited to Excel, Outlook, Word, and PowerPoint Strong analytical skills and logical thought processes with the ability to identify and resolve complex and sensitive regulatory (rate/tariff) issues/problems Proven oral and written communication and presentation skills, with ability to communicate with a variety of individuals and personalities at all levels internally and outside the organization Ability to successfully perform the required and expected duties with minimal direct supervision Must be able to successfully perform multiple tasks with strict deadlines Ability to organize and prioritize work effectively, reprioritize as new demands arise, and maintain strict confidentiality Ability to work with a team, take direction from supervisor(s), focus attention on details, follow work rules and adhere to established work schedules Ability to identify, understand and meet/exceed expectations in an employee/employer relationship Must be able to perform all essential functions of the job Must possess and maintain a valid driver license and a driving record satisfactory to the company and its insurers Preferred Experience, Skills and Knowledge Experience as an accounting witness Experience with Colorado, Nebraska, Wyoming and FERC natural gas regulation and the statutes affecting the natural gas industry Regional experience with interstate natural gas pipelines and regulated distribution systems Regulatory relations experience state utility regulatory commissions and the FERC Negotiation and public speaking experience Experience with MS Access database is helpful At SourceGas, you’ll enjoy a highly competitive salary along with an outstanding benefits package that includes health, dental, vision, and life insurance, 401(k) with employer contribution, and much, much more. SourceGas is an Equal Opportunity Employer. Qualified applicants are considered for positions without regard to race, color, religion, sex, national origin, age, citizenship status, marital status, medical condition, physical or mental disability or any other legally protected status. EOE/M/F/D/V To submit your application for this position, visit:https://home.eease.com/recruit2/?id=487366&t=1 IN ADDITION TO THE RÉSUMÉ, APPLICANTS ARE STRONGLY ENCOURAGED TO SUBMIT A COVER LETTER FOR THIS POSITION. PLEASE UTILIZE THE "NOTES" FIELD WITHIN THE ONLINE APPLICATION TOOL IN ORDER TO SUBMIT YOUR COVER LETTER.