Title: Manager, Regulatory Operations
Department: R & D
Reports to: Associate Director, Regulatory Affairs
Classification: FT / Exempt
Location: Boulder, CO
Last Updated: May, 2017
miRagen Therapeutics, Inc. is a biopharmaceutical company founded to harness the power of microRNA (miRNA) biology. The company combines strong in-house expertise in microRNA biology and chemistry with external partnerships and academic collaborations that leverage best-in-class technologies. Together with its strategic partners, miRagen is focused on the discovery and development of innovative microRNA-based therapeutics in disease areas with high unmet medical need.
miRagen Therapeutics is currently seeking a Regulatory Operations Manager to plan, execute, and complete high priority projects that support key regulatory strategies. The Regulatory Operations Manager will work collaboratively with scientific staff, management and stakeholders to define project scope, goals and deliverables and actively coordinate and manage all activities through to completion. Specific responsibilities include:
- Work within a cross-functional team to coordinate and prepare high quality, timely draft correspondence and regulatory submissions in both paper and electronic format;
- Ensure compliance of regulatory submissions to applicable regulations and guidelines, as well as internal document management standards;
- Coordinate with appropriate team members and stakeholders to resolve outstanding regulatory issues;
- Work directly with external contractors and collaborators, managing the chain of communication and updating regulatory project plans as necessary for accuracy and success;
- Coordinate and conduct regulatory project review sessions, determine frequency and content of status reports, and deliver routine updates including presentations;
- Facilitate the preparation for FDA meetings;
- Identify potential regulatory risks and propose options to mitigate risks;
- Keep apprised of new regulations, standards, policies, and guidance issued by relevant regulatory authorities;
- Provide input on project related budgets and ensure projects operate within capital and expense budget guidelines.
Suitable candidates will have an undergraduate or advanced degree in a scientific discipline with a minimum 5 years of experience working in Regulatory Operations in the pharmaceutical industry.
- Clear record of success as a Regulatory Operations Manager in a biopharma or pharmaceutical environment;
- Experience managing complex regulatory projects that span multiple years, systems and regulatory standards;
- Thorough knowledge of the drug development process;
- Possess and demonstrate an excellent understanding of FDA and international regulatory requirements and guidelines;
- Detailed familiarity with the content and structure of regulatory submissions, including the eCTD;
- Adept at prioritizing and completing tasks in a high-pressure environment;
- Proven leadership within a cross-functional project team;
- Demonstrated ability to anticipate and address regulatory issues related to drug development;
- Exceptional oral and written communication skills including excellent technical writing abilities;
- Solid foundation of scientific knowledge to facilitate understanding of all regulatory issues.
miRagen Therapeutics offers competitive pay and a comprehensive benefits package including medical, dental, life insurance, short-term disability and flex-spending. For additional information, please visit our website at www.miragentherapeutics.com. Interested candidates should email a cover letter and resume to email@example.com