Regulatory Affairs Director jobs in Oregon
Regulatory Affairs Director oversees regulatory matters and executes the strategy to ensure the organization complies with applicable regulations. Develops processes and systems to ensure that all necessary licensing, filings, certifications, and permits are processed and monitored. Being a Regulatory Affairs Director establishes 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 Director investigates and addresses any reported issues of non-compliance. Requires a bachelor's degree. Typically reports to a director. The Regulatory Affairs Director typically manages through subordinate managers and professionals in larger groups of moderate complexity. Provides input to strategic decisions that affect the functional area of responsibility. May give input into developing the budget. To be a Regulatory Affairs Director typically requires 3+ years of managerial experience. Capable of resolving escalated issues arising from operations and requiring coordination with other departments. (Copyright 2024 Salary.com)
Recently Added Regulatory Affairs Director jobs
Sr Manager, Regulatory Affairs
- myGwork - LGBTQ+ Business Community
-
Hillsboro, OR
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
- 13 Days Ago
Sr Manager, Regulatory Affairs
- myGwork - LGBTQ+ Business Community
-
Corvallis, OR
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...
- 15 Days Ago
Sr Manager, Regulatory Affairs
- Thermo Fisher Scientific
-
Beaverton, OR
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...
- 16 Days Ago
Sr Manager, Regulatory Affairs
- myGwork - LGBTQ+ Business Community
-
Bend, OR
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...
- 16 Days Ago
Sr Manager, Regulatory Affairs
- myGwork - LGBTQ+ Business Community
-
Beaverton, OR
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...
- 16 Days Ago
Sr Manager, Regulatory Affairs
- Thermo Fisher Scientific
-
Bend, OR
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...
- 16 Days Ago
Regulatory Affairs Director jobs at Popular Companies
Head of Regulatory Affairs
- Kaye/Bassman International
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San Diego, CA
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Sr. Director of Regulatory Affairs - Oncology
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Boston, MA
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Director of Regulatory Affairs
- Verano
-
Chicago, IL
- Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
- 6/12/2024 12:00:00 AM
Director of Regulatory Affairs
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- Verano Holdings Corp. (CSE: VRNO) (OTCQX: VRNOF), one of the U.S. cannabis industry’s leading companies based on histori...
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Head of Regulatory Affairs
- Exegenesis Bio Inc
-
Ambler, PA
- Job Description Job Description Job Title: Head of Regulatory Science Reports to (Title): CEO Location: Remote, US Exemp...
- 6/11/2024 12:00:00 AM
Head of Regulatory Affairs
- EPM Scientific
-
- Our client, a clinical stage biotech company, is seeking an experienced and dynamic Head of Regulatory Affairs to join t...
- 6/10/2024 12:00:00 AM
Head of Regulatory Affairs
- Hiring Now!
-
West Hills, CA
- HELP US BRING THE GIFT OF HEALTH TO LIFE.Working at Pharmavite is an experience like no other. With a focus on complete ...
- 6/8/2024 12:00:00 AM
Director of Regulatory Affairs
- Catalyst Life Sciences
-
- Our client is actively looking for a (Senior) Director of RA/QA to join their growing team. This is a hybrid position su...
- 6/8/2024 12:00:00 AM
About Oregon
Oregon (/ˈɒrɪɡən/ (listen) ORR-ih-gən) is a state in the Pacific Northwest region on the West Coast of the United States. The Columbia River delineates much of Oregon's northern boundary with Washington, while the Snake River delineates much of its eastern boundary with Idaho. The parallel 42° north delineates the southern boundary with California and Nevada. Oregon is one of only four states of the continental United States to have a coastline on the Pacific Ocean.
Oregon was inhabited by many indigenous tribes before Western traders, explorers, and settlers arrived. An autonomous government ...
Source: Wikipedia (as of 04/11/2019). Read more from Wikipedia
Income Estimation for Regulatory Affairs Director jobs
$172,615 to $245,848
Most Popular Cities in Oregon for Regulatory Affairs Director Jobs
What does a Regulatory Affairs Director do?
Regulatory Affairs Director in Gary, IN
At the Healthcare Professionals Group, our experienced team of Regulatory & Quality recruitment consultants are ready to discuss a variety of Regulatory Affairs Director jobs with you.
February 18, 2020
Regulatory Affairs Director in Springfield, OR
The regulatory affairs director might engage in reading and responding to letters from the FDA, including any “warning letters” about unapproved activities or products.
December 04, 2019
Regulatory Affairs Director in Richmond, VA
The office of regulatory affairs is a dynamic work environment where communication with employees at all levels within the organization is extremely important.
December 05, 2019