myGwork - LGBTQ+ Business Community hiring Sr Staff Regulatory Affairs Specialist in Brownsville, Texas, United States | LinkedIn (2024)

This inclusive employer is a member of myGwork – the largest global platform for the LGBTQ+ business community. Work Schedule

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Job DescriptionAs 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.

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 WorkAs Sr Staff Regulatory Affairs Specialist, 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.

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.

Experience

• Minimum of 8 years related experience in the pharmaceutical industry or advanced degree with 6 years related experience.
• 2 years' leading a team

Knowledge, Skills, Abilities

• 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

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

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.

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Compensation And BenefitsThe 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 reimbursem*nt
• 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

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards