Regulatory Manager
US-AnywhereRemote in United States
More than 3 months ago
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Job Description
Position Summary:
The Regulatory Manager (RM) provides regulatory development advice and guidance for optimal conduct of clinical trials, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. The RM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function.
Essential functions of the job include but are not limited to:
Qualifications:
Minimum Required:
Preferred:
Other Required:
Competencies
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range
$113,000-$152,800 USD
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR[redacted]
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
The Regulatory Manager (RM) provides regulatory development advice and guidance for optimal conduct of clinical trials, ensuring timely preparation of well organized, quality regulatory submissions in compliance with applicable regulations. The RM coordinates and prepares regulatory documents for submission to Regulatory Authorities and/or Ethics Committees, as applicable. The RM maintains a current knowledge of regulations and guidance documents, providing analysis to project teams, as well as supporting and enhancing Precision for Medicines corporate Regulatory function.
Essential functions of the job include but are not limited to:
- Provides regulatory guidance throughout the clinical development life cycle
- Compile, coordinate and review applications to Regulatory Authorities including, but not limited to, CTA/IND, annual reports, routine amendments, scientific advice/regulatory authority meetings, orphan designations, pediatric planning, and marketing applications. Also provides strategic regulatory input as required.
- Develops and/or reviews documents intended for submission to the Regulatory Authorities and/or Ethics Committees to assure compliance with regulatory standards
- Serve as representative of Global Regulatory Affairs at project team meetings with both external and internal customers
- Works within a project team, and where necessary, leads project for the region or globally
- Oversee and coordinate Regulatory Affairs Specialists to achieve submission targets for contracted programs
- Maintenance of project plans, project trackers and regulatory intelligence tools as it pertains to assigned responsibilities and to keep Regulatory Leadership updated.
- Assist in development of Regulatory Affairs Specialists and other operational area staff, as required
- Provide input, as required, into regulatory strategy and timeline development for new study opportunities Assists in establishing company standards to ensure the highest quality of submitted information
- Participates in maintaining and executing on the corporate quality initiatives across business units within clinical solutions.
- Keeps abreast and continually expand knowledge of laws, regulations and guidelines governing drug development and approval
- Provides ICH GCP guidance, advice and training to internal and external clients
- Serve as representative of Global Regulatory Affairs at business development meetings
Qualifications:
Minimum Required:
- Bachelors degree, or equivalent experience, ideally in a scientific or healthcare discipline
- Computer literacy (MS Office/ Office 365)
- Fluent in English
Preferred:
- Graduate, postgraduate
- Possesses basic understanding of financial management
Other Required:
- 5+ years or more relevant regulatory affairs experience
- Informed knowledge of all aspects of the drug development process inclusive of regulatory milestones
- Specialized knowledge of regulatory activities for at least one major region (EU, US) including but not limited to submissions to Regulatory Authorities, including INDs/CTAs and amendments, Scientific Advice Procedures, and post-approval submissions
- Ability to understand clinical and pre-clinical study results, to help in its interpretation for regulatory positions and strategy
- Knowledgeable of clinical trials methodology, including a working knowledge of protocols and indications being studied
- Knowledge and expertise with relevant regulations and guidance supporting pharmaceutical development
- Availability for domestic and international travel including overnight stays
Competencies
- Strong interpersonal skills and a proven ability to contribute to a team environment involving balancing the demands stemming from multifaceted research activities
- Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates
- Ability to manage multiple and varied tasks in a fast-moving environment, good record-keeping skills
- Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment
- Motivates other members of the project team to meet timelines and project goals
- Flexible attitude with respect to work assignments, and new learning
- Resolves project related problems and prioritize workload to meet deadlines with little support from management
- Focuses on continuous improvement, including the ability to make proactive assessments on how to make processes more efficient and people more effective
- Collects data of consistently high standard
- Communicates both verbally and in written form in an acceptable manner
- Conducts formal presentations to a wide variety of audiences including colleagues, investigative staff, and clients with a high level of proficiency
Precision is required by law in some states or cities to include a reasonable estimate of the compensation range for this role. This compensation range takes into account the wide range of factors that are considered in making compensation decisions including but not limited to: skill sets, experience and training, licensure and certifications, and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. At Precision, it is not typical for an individual to be hired at or near the top of the range for their role and compensation decisions are dependent on the facts and circumstances of each case. This role is also eligible for a discretionary annual bonus, health insurance, retirement savings benefits, life insurance and disability benefits, parental leave, and paid time off for sick leave and vacation, among other benefits.
Reasonable estimate of the current range
$113,000-$152,800 USD
Any data provided as a part of this application will be stored in accordance with our Privacy Policy. For CA applicants, please also refer to our CA Privacy Notice.
Precision Medicine Group is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law. © 2020 Precision Medicine Group, LLC
If you are an individual with a disability and require a reasonable accommodation to complete any part of the application process or are limited in the ability or unable to access or use this online application process and need an alternative method for applying, you may contact Precision Medicine Group at QuestionForHR[redacted]
It has come to our attention that some individuals or organizations are reaching out to job seekers and posing as potential employers presenting enticing employment offers. We want to emphasize that these offers are not associated with our company and may be fraudulent in nature. Please note that our organization will not extend a job offer without prior communication with our recruiting team, hiring managers and a formal interview process.
About Precision for Medicine
Learn More About Precision for MedicineARIZ Precision Medicine is a biotechnology company that develops drug candidates for cancer.The acronym stands for a methodology of solving big problems, by breaking the big problem into smaller and smaller problems. This way the company can start at the beginning, the cause of cancer and design drugs that can resolve a specific individual cancer as well as all cancers. ARIZ Precision Medicine uses this methodology to design a specific way to stop the cause of cancer, then target and protect the delivery system and finally, concentrate the drug inside the cancer cell leaving normal cells undamaged.
There has never been a better time to join the global team at Precision for Medicine—the forefront group of professionals dedicated to transforming healthcare through innovation and specialized care.
Join Precision for Medicine’s leading team to assist some of the most innovative healthcare providers and researchers in mastering their operational and research challenges.
Transform healthcare practices and patient outcomes with the brightest minds at Precision for Medicine. This is where technology, medical expertise, and digital innovation converge to lead the healthcare industry forward.
Lead from a unique position in the marketplace, at the intersection of biotechnology, patient data, and groundbreaking research.
Work with a global team of healthcare and technology advisors to help clients navigate through complex medical and regulatory landscapes.
Collaborate with a dedicated group of professionals focused on advancing medicine and improving lives.
The team is building a market-leading career development framework to help some of the most talented professionals advance their careers in the medical and biotechnological fields.
Join a group of dedicated experts at the intersection of healthcare, technology, and innovation.
Deliver targeted healthcare solutions through a depth and breadth of scientific expertise and innovation that’s second to none.
Engage in wide-ranging projects utilizing cutting-edge technology and harness the capabilities of a team renowned for its commitment to medical innovation and patient care.
Advance as far as your ambition takes you with limitless opportunities to grow your career supported by unmatched training, development, and certification support.
Discover how Precision for Medicine is leading the way in predictive healthcare solutions and personalized medicine, enhancing patient care across the globe.
The combined expertise, global reach, and innovative solutions help clients overcome challenges and lead advancements in the healthcare industry.
Professionals around the globe are turning to Precision for Medicine for new strategies and solutions to drive significant advancements in healthcare.
Search open positions that match your skills and interests. Precision for Medicine looks for passionate, curious, creative, and solution-driven team players.
SEARCH PRECISION FOR MEDICINE JOBS
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Precision for Medicine Careers
There has never been a better time to join the global team at Precision for Medicine—the forefront group of professionals dedicated to transforming healthcare through innovation and specialized care.
Work You’ll Do
Join Precision for Medicine’s leading team to assist some of the most innovative healthcare providers and researchers in mastering their operational and research challenges.
Transform healthcare practices and patient outcomes with the brightest minds at Precision for Medicine. This is where technology, medical expertise, and digital innovation converge to lead the healthcare industry forward.
Lead from a unique position in the marketplace, at the intersection of biotechnology, patient data, and groundbreaking research.
Work with a global team of healthcare and technology advisors to help clients navigate through complex medical and regulatory landscapes.
Collaborate with a dedicated group of professionals focused on advancing medicine and improving lives.
Introducing the Precision for Medicine Career Opportunities
The team is building a market-leading career development framework to help some of the most talented professionals advance their careers in the medical and biotechnological fields.
Do Innovative Work
Join a group of dedicated experts at the intersection of healthcare, technology, and innovation.
Drive Innovative Solutions
Deliver targeted healthcare solutions through a depth and breadth of scientific expertise and innovation that’s second to none.
Be Part of a Great Team
Engage in wide-ranging projects utilizing cutting-edge technology and harness the capabilities of a team renowned for its commitment to medical innovation and patient care.
Future-proof Your Career
Advance as far as your ambition takes you with limitless opportunities to grow your career supported by unmatched training, development, and certification support.
Explore
Discover how Precision for Medicine is leading the way in predictive healthcare solutions and personalized medicine, enhancing patient care across the globe.
The Precision for Medicine Difference
The combined expertise, global reach, and innovative solutions help clients overcome challenges and lead advancements in the healthcare industry.
Professionals around the globe are turning to Precision for Medicine for new strategies and solutions to drive significant advancements in healthcare.
Stay Connected
Join the Team
Search open positions that match your skills and interests. Precision for Medicine looks for passionate, curious, creative, and solution-driven team players.
SEARCH PRECISION FOR MEDICINE JOBS
Keep Up to Date
Stay ahead with career tips, insider perspectives, and industry-leading insights you can put to use today—all from the people who work at Precision for Medicine.
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