Senior Regulatory Affairs and Quality Assurance Professional Job at Life Science Talent (København)

Regulatory Affairs Senior Officer

Reporting to the Head of Regulatory Filings, located in Jersey, you will be resp...

Location

Luxembourg , Luxembourg

Salary:

Not provided

Alter Domus

Expiration Date

Until further notice

Requirements

A minimum of 5 years of experience in Financial Services, with a minimum of 2 years in a Regulatory Compliance or Filings execution role
Solid technical knowledge and practical experience in operational regulatory compliance and filing requirements (not just strategic framework design)
Exceptional organizational skills and unwavering attention to detail are critical for register maintenance and filing accuracy
Proven track record of independently and accurately executing complex, repetitive compliance tasks and meeting strict deadlines
The ideal candidate must demonstrate a passion for continuous learning and professional development
Demonstrate clear, concise, and professional communication skills, especially in articulating data requirements and status updates to stakeholders
Strong practical analytical abilities to identify and resolve data discrepancies or filing issues quickly

Job Responsibility

Ensure the correct discharge of all regulatory processes, including all relevant regulatory notices, applications, and files
Execute the preparation, quality assurance and timely submission of regulatory filings, notices, and applications, ensuring all documentation is complete, accurate, and ready for review by the Head of Regulatory affairs (located in Jersey)
Assist the Head of Regulatory affairs in the maintenance of the centralized regulatory register, accurately tracking all incoming and outgoing regulatory notices, applications, and compliance activities
Ensure strict adherence to the global compliance framework developed by the Regulatory Affairs team, including following all defined processes, timelines, and reporting responsibilities
Maintain comprehensive, audit-ready files and supporting documentation for all regulatory submissions
Support the Regulatory Affairs team in implementing new processes, procedures, and systems related to regulatory filings and data management
Coordinate closely with internal stakeholders (Risk, Compliance, Legal, SMEs) to gather necessary data and sign-offs required for accurate regulatory submissions
Conduct internal checks and controls on submission data before final delivery to applicable sign-off

What we offer

Support for professional accreditations such as ACCA and study leave
Flexible arrangements, generous holidays, plus an additional day off for your birthday
Continuous mentoring along your career progression
Active sports, events and social committees across our offices
24/7 support available from our Employee Assistance Program
The opportunity to invest in our growth and success through our Employee Share Plan
Plus additional local benefits depending on your location

Fulltime

Senior Regulatory Affairs Specialist

Reporting to the Senior Manager, Regulatory Affairs within the RA Department, th...

Location

United States , St Louis

Salary:

74000.00 - 90000.00 USD / Year

STERIS

Expiration Date

Until further notice

Requirements

Bachelor's Degree
At least 5 years professional experience including regulatory affairs, quality systems, internal auditing, applicable scientific or technical functions
Self-starter with demonstrated organizational, project management, time management and problem-solving skills
Experience working effectively on cross-functional teams
Demonstrated ability to balance multiple high priority responsibilities on-time and effectively
Excellent PC skills, including Microsoft Office applications including Excel, Word and PowerPoint
Understanding of chemical / scientific industry
Experience with internal audit process and quality systems
Experience with Healthcare regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries

Job Responsibility

Identify regulatory requirements for new products or product enhancements early in the product development cycle
Assure that product registration and maintenance fees are tracked and paid
Gather information to support regulatory submissions. Use this information to prepare regulatory submissions in a complete, thorough format to support STERIS product claims
Review product revision requests to assure compliance with regulatory requirements
Work on product teams to develop regulatory strategy based on regulatory submission requirements
Review and approve labeling and marketing literature
Support Manager, Regulatory Affairs and other Regulatory Affairs staff with all regulatory matters
Provide Regulatory support for product assessments, Safety Data Sheet generation, and Customer inquiries to the Healthcare team
Work with direct Supervisor and senior internal stakeholders to identify key initiatives, which may be affect by present or emerging policies. As part of this, develop and recommend government affairs policy positions to upper management
Other duties as assigned

What we offer

Market Competitive Pay
Extensive Paid Time Off and (9) added Holidays
Excellent Healthcare, Dental and Vision Benefits
Long/Short Term Disability Coverage
401(k) with a company match
Maternity and Paternity Leave
Additional add-on benefits/discounts for programs such as Pet Insurance
Tuition Reimbursement and continued education programs
Excellent opportunities for advancement in a stable long-term care

Fulltime

Senior Manager, Central Regulatory Affairs

The Sr. Manager - Central RA is a pivotal senior leadership role based out of Ba...

Location

India , Bangalore

Salary:

Not provided

Baxter

Expiration Date

Until further notice

Requirements

Advanced degree in Pharmacy, Life Sciences, Biotechnology, Regulatory Affairs, or related discipline
12+ years of progressive experience in global regulatory affairs within the pharmaceutical, biotechnology, or medical device industry, with significant people management and team development
Expert knowledge of global regulatory requirements and guidelines (FDA, EMA, TGA, MHRA, etc.), with a strong track record of successful regulatory submissions and approvals
Proven leadership skills with the ability to influence and collaborate effectively across diverse global teams and stakeholders
Strategic thinker with the ability to navigate complex regulatory challenges and drive regulatory initiatives that support business growth and compliance objectives

Job Responsibility

Develop and implement global regulatory strategies for Baxter products (both Drugs and Devices) aligned with business objectives to support product lifecycle spanning timely Initial /Geo-expansion/ Change controls and Variations registrations enabling speedy commercialization across diverse markets
Drive transformation initiatives to improve regulatory processes and ensure compliance with changing regulatory requirements
Collaborate with cross-functional teams to identify opportunities for innovation and implement solutions
Lead the preparation and submission of regulatory documents, including lifecycle management submissions, to regulatory authorities globally
Ensure that all submissions are accurate, complete, and compliant with regulatory requirements
Engage and collaborate with cross-functional teams, including R&D, Quality, and Manufacturing, to gather necessary information and ensure alignment
Oversee the preparation, review, and submission of both Drug and Device Lifecycle management regulatory filings (e.g., Initial and Geo-expansion registrations, change controls, Variations, Tender support, Acquisition Integration /Divestiture related Legal Entity name changes etc.) to health authorities across global markets
Ensure timely approvals and compliance with regulatory standards and post-market requirements across multiple jurisdictions
Establish and maintain standardized regulatory processes, procedures, and documentation within Central RA to drive operational efficiency and regulatory compliance across GRA
Generate future readiness with implementation of best practices and continuous improvement initiatives to optimize regulatory operations and ensure consistency across regions for registrations, Change Control Management, tender Support, Geo-expansion/Initial registrations

Senior Regulatory Specialist

At GSK, we unite science, technology, and talent to get ahead of disease togethe...

Location

India , Bengaluru

Salary:

144750.00 - 241250.00 PLN / Year

GSK

Expiration Date

Until further notice

Requirements

Bachelor's degree in Chemistry, pharmacy or other related biological science or technical bachelor's degree
English language skills
Knowledge of drug development and manufacturing and supply processes
Knowledge of worldwide CMC post-approval regulatory requirements
Can identify areas for personal professional growth in global regulatory affairs with appropriate support from line manager
Service orientation, customer-focused

Job Responsibility

Responsible for the timely delivery of regulatory activities of multiple projects across dosage forms
Represents New Registration CMC, on Regulatory Networks and Matrix Teams providing guidance to Global Supply Chain (GSC), Commercial, Quality Assurance, 3rd Party Contract Management (via ESQ) and Office of the Chief Medical Officer (OCMO) to produce appropriate components for global regulatory dossiers
Will serve as a mentor/trainer for new team members
May act as a Subject Matter Expert for specific areas for consultation within the team/ department as well as externally outside the department
Independently and confidently executes agreed dossier strategy
Independently manages multiple project simultaneously
assignments will range in complexity but more complex work is expected
Independently completes data assessment to ensure dossier is fit for purpose
Identifies risks associated with submission data and information packages
Escalates issues with line manager that have business impact

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes
Annual bonus
Eligibility to participate in our share based long term incentive program

Fulltime

Regulatory Affairs Specialist

An excellent opportunity to join a leading global food business based in central...

Location

United Kingdom , London

Salary:

45000.00 - 50000.00 GBP / Year

The People Co.

Expiration Date

Until further notice

Requirements

5+ years of technical or regulatory experience in food, feed or ingredients
Highly analytical, and organised with keen attention to
Must be able to identify problems and provide systematic
Be able to multi-task and have excellent communication skills
Real team player – Must be able to work with senior and junior employees in a professional and inclusive manner
A high level of business English is essential
The successful candidate will be self-motivated
Strong administration skills on Microsoft Office Packaging on Windows

Job Responsibility

Ensure regulatory compliance with food and feed safety, quality and defence as it relates to UK, EU and GFSI (BRC) requirements, Organic, Halal, FAMI QS and Kosher
Monitor changes in legislation and regulatory requirements, proactively assessing the impact on business and updating the senior management team's compliance protocols as necessary
Support the development and implementation of regulatory strategies for existing ingredients and new ingredients/products in the UK and EU regions ensuring compliance to but not limited to Allergens, REACH, Novel food, Packaging Food Contact Materials, Food Law and labelling, Feed laws and labelling, Residues and Contaminants, Natural and Botanical ingredients etc
Provide regulatory review of product compliance when an in-depth analysis/review is needed for the quality department. Example of review provided: Novel food status, specific application status, claims, labelling
Coordinate with authorities for all work required, such as authorisation and licenses
Support the design and maintenance of Prinova Specification, ensure all information is correct and meets relevant EU regulation requirements
Provide training for the quality and technical teams in Europe
Actively support QA department tasks according to workload and priorities, as required
Provide support to the commercial and marketing team to verify regulatory compliance
Assisting, as required, in the management of crises and incidents as part of the management team

Executive Director, HEOR Modeling

As part of Parexel Consulting, you will play a vital role in helping biopharmace...

Location

United Kingdom

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Numerous years’ experience in the life sciences or consulting industries with many years of experience managing direct reports, directing teams and projects
10+ years management experience
15+ years general experience in the field
Minimum of a Bachelor’s Degree in a Scientific or Technical Discipline

Job Responsibility

Monitors profitability of multiple projects through active involvement in the preparation of project plans and management of project budgets
Prevents and resolves issues with revenue recognition
Works within a team environment or individually based on project needs
Provides guidance to project team members and acts as a mentor to junior staff
Works within broad project guidelines and leads issue and conflict resolution
Prioritizes own workload and prioritizes the workload of the project team in order to achieve the project scope and objectives
Capitalizes on opportunities to improve project efficiency, results or team performance and proactively acts
Leverages information from previous projects or other client work to efficiently complete assigned project activities as well as facilitate business decisions
Produces quality work that meets the expectations of Parexel HEOR Consulting and the client
Reviews the work of colleagues for content and quality to ensure the expectations of the client and are met

Dean, Malcolm Baldrige School of Business

Post University invites applications for the position of Dean, Malcolm Baldrige ...

Location

United States , Waterbury

Salary:

Not provided

Buffkin / Baker

Expiration Date

Until further notice

Requirements

Terminal degree reflective of one or more disciplines within the Malcolm Baldrige School of Business
Minimum of five years of experience in higher education leadership or a related professional field
Significant online experience is strongly preferred
Knowledge of and experience in adult education (theory, pedagogy, and andragogy) as it relates to online, on campus and blended learning modalities
Demonstrated knowledge of current research and state and/or national initiatives to enhance students access, persistence, and success
Proficiency in designing and teaching courses online
demonstrated success in academic higher education program and curriculum development
experience with faculty/staff professional development
Experience with budgets and fiscal management
A proven record of effective, inspirational leadership through collaborative and shared decision-making

Job Responsibility

Model Post's non-negotiable behaviors with all audiences, all the time
Adopt innovative strategies and data informed decision-making in support of Post's smart growth as a global employer
Ensure academic integrity in all academic department informational communications – internal or external
Demonstrate expertise in effective, student-centered, success-oriented, and ethical leadership
Establish and launch the school's mission, shared vision, and identity
Build the strength relevancy of the MBSoB name locally, regionally, and nationally by establishing relationships with counterpart institutions, transfer institutions, local business/industry partners, K-12 partners, and the Post University community
Actively participate in the university's senior leadership team to support the university-wide strategic planning process with the specific accountability and advocacy for the school
Provide leadership in the development, enhancement, and review of academic policies
Ensure timely and transparent information communication across the School, Academic Affairs, and/or the University
Enhance the ethos of collaboration and respect among all Faculty, Associates, and Students

Fulltime

Senior Mechanical Engineer

SP Industries Inc., an ATS company is looking for a Senior Mechanical Engineer t...

Location

United States , Stone Ridge

Salary:

100000.00 - 135000.00 USD / Year

ATS Automation Tooling Systems Inc.

Expiration Date

Until further notice

Requirements

Bachelor’s degree in Mechanical Engineering or related field
advanced degree preferred
Minimum of 10 years of experience in mechanical engineering roles, with a focus on equipment or product design and development
Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and engineering simulation tools (e.g., ANSYS, COMSOL)
Strong understanding of regulatory requirements, such as FDA cGMP, ISO 13485, and ASME BPE, relevant to pharmaceutical equipment design and manufacturing
Experience leading multidisciplinary engineering teams and driving projects from conception to completion
Excellent problem-solving skills and the ability to apply engineering principles to develop innovative solutions
Effective communication skills, with the ability to collaborate effectively with internal teams and external stakeholders
Proven track record of delivering high-quality, compliant, and commercially successful products on schedule and within budget
Ability to manage multiple projects simultaneously and prioritize tasks effectively

Job Responsibility

Lead the design and development of mechanical components and systems, from concept to production
Assume lead engineer responsibilities during New Product Development projects
Lead reliability testing planning and execution and use tools like FMEA to inform activities
Conduct engineering analyses, including structural, thermal, and fluid dynamics simulations, to optimize performance and ensure compliance with industry standards and regulations
Collaborate with cross-functional teams, including R&D, manufacturing, quality assurance, and regulatory affairs, to ensure seamless integration of mechanical systems into final products
Drive continuous improvement initiatives to enhance product reliability, manufacturability, and cost-effectiveness
Provide technical expertise and guidance to junior engineers and contribute to their professional development
Support product testing, validation, and troubleshooting activities, both in-house and at customer sites as necessary

What we offer

We provide a wide range of innovative and high-quality scientific products that improve people’s lives
We offer a robust health and welfare benefits package that includes Life, Health, Dental, Vision
We offer 401(K) including company match, Paid Time Off annually + Paid Holidays
You will enjoy career Advancement Opportunities and Tuition Assistance to help you achieve your goals and continue your career growth

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Senior Regulatory Affairs and Quality Assurance Professional

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