Regulatory Affairs Manager jobs in Utah
Regulatory Affairs Manager manages regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Implements processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Manager utilizes established monitoring policies and procedures to ensure compliance with existing regulations. Anticipates new or changing regulations and coordinates with internal stakeholders to develop strategies to address changes in product, operations, or testing requirements. Additionally, Regulatory Affairs Manager investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Manager manages subordinate staff in the day-to-day performance of their jobs. True first level manager. Ensures that project/department milestones/goals are met and adhering to approved budgets. Has full authority for personnel actions. To be a Regulatory Affairs Manager typically requires 5 years experience in the related area as an individual contributor. 1 - 3 years supervisory experience may be required. Extensive knowledge of the function and department processes. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Manager jobs
Sr Manager, Regulatory Affairs
- myGwork - LGBTQ+ Business Community
-
Draper, UT
FULL_TIME
-
This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ business community.
Job Description
As part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
Location/Division Specific Information
At Thermo Fisher Scientific, the Regulatory Affairs function plays a vital role in ensuring compliance with the ever-evolving global regulations governing our industries. With a commitment to upholding the highest standards of quality, safety and compliance, our Regulatory team navigates complex landscapes to bring innovative products to market. They collaborate closely with cross-functional teams, such as Research and Development, Quality Assurance, and Manufacturing, to develop and deliver regulatory strategies to obtain vital approvals, and maintain regulatory compliance throughout the product lifecycle. Our Regulatory professionals possess a deep understanding of international regulations and guidelines, staying abreast of emerging trends and industry best practices. They are champions of patient safety, working diligently to meet regulatory requirements while driving business growth. Join our dynamic Regulatory Affairs team and contribute to our mission to enable our customers to make the world healthier, cleaner and safer.
Discover Impactful Work
As Sr. Manager, Regulatory Affairs, you will assume a key role in the interpretation and dissemination of global regulations, guidelines, and emerging industry developments that directly influence our business. Applying your expertise, you will actively contribute to the continuous enhancement and alignment of our regulatory tools, including information systems, with our strategic objectives. You will manage regulatory professional(s) providing guidance and support to our development teams, ensuring that our products meet all necessary requirements.
A Day In The Life- Interpret and communicate impact of relevant global regulations, guidelines and evolving regulatory trends.
- Manage maintenance and improvements to regulatory tools, including regulatory information systems to meet organization objectives.
- Provide regulatory expertise and support to the business leadership.
- Develop regulatory strategy accounting for global requirements and desired marketing claims.
- Author and/or review regulatory submissions.
- Provide regulatory direction to product development teams.
- Oversee regulatory compliance of advertising and promotional materials.
- Oversee compliance with license registration, listing and renewal requirements.
- Provide leadership and guidance for the reporting and communicating of product associated complaints, recalls, market withdrawals and vigilance reports as applicable.
- Direct the process for evaluating and processing product change requests including impact assessment.
- Propose innovative regulatory options for new products or claims.
- Manage departmental budget.
- Determine work priorities align with business, functional and company goals.
- Manage a team of regulatory professionals
- Communicate a clear plan and empower the team to achieve goals and defined success metrics.
Education- Bachelor's degree in science, pharmacy or related field required.
- Minimum of 8 years related experience in the pharmaceutical industry or advanced degree with 6 years related experience.
- 2 years' leading a team
- Extensive knowledge of regulatory requirements, and their impact the product development process.
- Ability to evaluate and analyze potential regulatory impact on new and existing products and provide strategic recommendations to minimize risks and ensure compliance.
- Extensive experience in compiling and submitting regulatory filings: Possess a track record of leading successful complex regulatory filings.
- Demonstrated ability to navigate regulatory authorities' requirements and effectively communicate with them to ensure timely and accurate submissions.
- Exhibit excellent communication skills to effectively interact with internal customers, regulatory authorities, and cross-functional teams.
- Clearly convey sophisticated regulatory concepts, strategies, and requirements in a concise and persuasive manner. Strong presentation skills are also necessary to engage and influence key decision-makers.
- Demonstrated advanced organizational and time management skills to efficiently prioritize and manage multiple complex projects simultaneously. Possess the ability to allocate resources effectively, set realistic deadlines, and adapt to changing priorities while maintaining high productivity and quality standards.
- Seasoned people leader who builds a positive workplace that promotes partnership, collaboration, and innovation
- Regular interaction with cross-functional teams, such as Research and Development, Product Management, Marketing, Quality Assurance, and Manufacturing.
- Interaction with Regulatory authorities.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected statuses.
Our Mission is to enable our customers to make the world healthier, cleaner, and safer. As one team of 125,000 colleagues, we provide an inclusive culture while sharing a common set of values - Integrity, Intensity, Innovation, and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation, and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
Accessibility/Disability Access
Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.- This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.
The salary range estimated for this position based in New York is $140,000.00-$160,000.00.
This Position May Also Be Eligible To Receive a Variable Annual Bonus Based On Company, Team, And/or Individual Performance Results In Accordance With Company Policy. We Offer a Comprehensive Total Rewards Package That Our U.S. Colleagues And Their Families Can Count On, Which Includes- A choice of national medical and dental plans, and a national vision plan, including health incentive programs
- Employee assistance and family support programs, including commuter benefits and tuition reimbursement
- At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
- Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
- Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
- Just Posted
Sr Manager, Regulatory Affairs
- Thermo Fisher Scientific
-
Draper, UT
FULL_TIME
- As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to en...
- Just Posted
Sr Manager, Regulatory Affairs
- myGwork - LGBTQ+ Business Community
-
Hyrum, UT
FULL_TIME
- This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ business community. Job DescriptionAs part of the Thermo Fisher Scientific team, you'll discover meaningful w...
- Just Posted
Sr Manager, Regulatory Affairs
- Thermo Fisher Scientific
-
Hyrum, UT
FULL_TIME
- As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to en...
- Just Posted
Sr Manager, Regulatory Affairs
- Thermo Fisher Scientific
-
South Jordan, UT
FULL_TIME
- As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to en...
- 2 Days Ago
Sr Manager, Regulatory Affairs
- myGwork - LGBTQ+ Business Community
-
South Jordan, UT
FULL_TIME
- This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ business community. Job DescriptionAs part of the Thermo Fisher Scientific team, you'll discover meaningful w...
- 2 Days Ago
Regulatory Affairs Manager jobs at Popular Companies
Regulatory Affairs Manager
- Mastech Digital
-
Oakland, CA
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- SS White Dental
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- JSHealth Vitamins
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Regulatory Affairs Manager
- Dental Technologies Inc
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Lincolnwood, IL
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Regulatory Affairs Manager
- Catalyst Life Sciences
-
Chicago, IL
- Opportunity to join a global diagnostics company at their HQ just outside of Chicago, focused on the strategy for existi...
- 5/31/2024 12:00:00 AM
Regulatory Affairs Manager
- Blueroot Health™
-
- PURPOSE STATEMENT: This position will be responsible for managing and coordinating implementation of regulatory requirem...
- 5/31/2024 12:00:00 AM
Regulatory Affairs Manager
- Formulated Solutions
-
Largo, FL
- THE COMPANY: Formulated Solutions is redefining the Pharmaceutical and Self-Directed Consumer Healthcare CDMO experience...
- 5/30/2024 12:00:00 AM
Regulatory Affairs Manager
- Procter & Gamble
-
Reading, England
- Job Location Reading Job Description P&G is a leading global consumer goods company whose winning brands are Procter & G...
- 5/22/2024 12:00:00 AM
About Utah
Utah is known for its natural diversity and is home to features ranging from arid deserts with sand dunes to thriving pine forests in mountain valleys. It is a rugged and geographically diverse state that is at the convergence of three distinct geological regions: the Rocky Mountains, the Great Basin, and the Colorado Plateau.
Utah is one of the Four Corners states, and is bordered by Idaho in the north, Wyoming in the north and east; by Colorado in the east; at a single point by New Mexico to the southeast; by Arizona in the south; and by Nevada in the west. It covers an area of 84,899 sq mi ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Manager jobs
$131,683 to $185,740
Most Popular Cities in Utah for Regulatory Affairs Manager Jobs
What does a Regulatory Affairs Manager do?
Regulatory Affairs Manager in Wichita Falls, TX
Other names for this job might include Clinical Trials Systems Administrator, Global Regulatory Affairs Manager, Regulatory Administrator, Regulatory Affairs Director, Regulatory Affairs Manager, Regulatory Affairs Portfolio Leader, Regulatory Consultant, Regulatory Leader, Regulatory Process Manager, Regulatory Product Manager.
January 17, 2020
Regulatory Affairs Manager in Baltimore, MD
Lead strategic contributions and initiatives to develop regulatory services and improve current processes and procedures.
January 18, 2020
Regulatory Affairs Manager in Fort Lauderdale, FL
Regulatory Domain Support for business development, including solutioning and developing innovative solutions, creation of materials for and participation in sales pursuits, key client meetings, bid defences for RFIs and RFPs.
December 04, 2019