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  • Emplois similaires à : Legislative/Regulatory Counsel
IrishJobs
Senior Counsel - EU Product & Chemical Regulatory Compliance (f/m/d)IrishJobs • Ireland
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IrishJobs

Senior Counsel - EU Product & Chemical Regulatory Compliance (f/m/d)

IrishJobs
  • IE
    Ireland
  • IE
    Ireland
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À propos

The Opportunity: This is an exciting opportunity to join Avantor as Senior Counsel and be at the forefront of our new Product & Chemical Regulatory function for the EU! Avantor is a leading global provider of mission-critical products and services to customers in the biopharma, healthcare, education & government, and advanced technologies & applied materials industries. This brand-new position offers a unique opportunity to shape the processes and be a member of the legal team, driving Avantor's operations across Europe and in Germany. Reporting to the VP & Deputy General Counsel, Regulatory, you'll play a pivotal role in navigating complex regulatory frameworks across Europe, with a strong emphasis on product regulatory compliance and trade regulations. You will provide strategic legal counsel to Regulatory Affairs, Quality Assurance, and Commercial leadership, as well as provide expert support to other Avantor lawyers to mitigate legal risks. Ideally, you have experience in the pharmaceutical, medical device, chemical or other highly regulated industries and possess a high degree of business acumen, understand business drivers, and you are able to influence policy development and mitigate legal risks to the company to enable the business to grow and thrive in a dynamic, evolving global landscape. Embrace the chance to make a significant impact and be part of innovation that we create together! Location: Germany or UK preferred (other EU locations will also be considered) What we're looking for: Education: Law degree (LLM or equivalent) and registered as an attorney in at least one European jurisdiction. Experience: 10+ years of legal experience, preferably from working for a leading law firm and/or multinational corporation, with 5-7 years of experience specializing in European regulatory law within the pharmaceutical, chemical, medical device, or other highly regulated industries. Experience collaborating across a matrixed business and legal environment. Expertise: In-depth knowledge of EU regulatory frameworks, including CLP, REACH, and GMP guidelines. Skills: Strong analytical and problem-solving abilities, excellent communication and negotiation skills, and the ability to work effectively in cross-functional teams. Languages: Proficiency in English is required and at least one other European language is preferred. How you will thrive and create an impact: Legal Advisory: Provide expert legal advice and guidance to senior management and legal colleagues on European regulations, directives, and policies impacting the business, including REACH, CLP, MDR/IVDR, GMP guidelines, pharmaceutical and/or medical device law, regulations, and guidance related to the development of and commercialization of products, import/export law and environmental regulations. Regulatory Liaison Experience: Proven ability to engage with regulatory authorities (i.e. EMA, ECHA, NCAs), draft regulatory responses, facilitate audits, and advocate for the company in policy discussions. Compliance Oversight: Develop and implement compliance strategies to ensure adherence to European regulatory requirements, including adherence to EU and international trade regulations, including customs classifications, Incoterms, duty drawback processes, and trade sanctions. Conduct investigations as directed. Quality Assurance: Direct support for compliance audits, corrective actions, and continuous improvement initiatives. Regulatory Submissions: Assist in the preparation and review of submissions to regulatory authorities such as the EMA, ECHA, or national agencies. Stakeholder Communication: Collaborate with internal and external stakeholders, including government bodies, industry associations, and cross-functional teams, to address regulatory issues. Policy Monitoring: Develop and implement internal policies and procedures to ensure ongoing compliance with evolving regulations. Stay updated on legislative changes and industry trends, assessing their impact on the organization and recommending proactive measures. Risk Management: Identify and mitigate legal risks related to regulatory compliance, including field actions. Training and Education: Conduct training sessions to enhance awareness of regulatory requirements within the organization. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer. Why Avantor? Dare to go further in your career. Join our global team of 14,000+ associates whose passion for discovery and determination to overcome challenges relentlessly advances life-changing science. The work we do changes people's lives for the better. It brings new patient treatments and therapies to market, giving a cancer survivor the chance to walk his daughter down the aisle. It enables medical devices that help a little boy hear his mom's voice for the first time. Outcomes such as these create unlimited opportunities for you to contribute your talents, learn new skills and grow your career at Avantor. We are committed to helping you on this journey through our diverse, equitable and inclusive culture which includes learning experiences to support your career growth and success. At Avantor, dare to go further and see how the impact of your contributions set science in motion to create a better world. Apply today! EEO Statement: We are an Equal Employment/Affirmative Action employer and VEVRAA Federal Contractor. We do not discriminate in hiring on the basis of sex, gender identity, sexual orientation, race, color, religious creed, national origin, physical or mental disability, protected Veteran status, or any other characteristic protected by federal, state/province, or local law. If you need a reasonable accommodation for any part of the employment process, please contact us by email at and let us know the nature of your request and your contact information. Requests for accommodation will be considered on a case-by-case basis. Please note that only inquiries concerning a request for reasonable accommodation will be responded to from this email address. Privacy Policy: We will use the personal information that you have submitted to us in order to consider your application for the relevant role. Your privacy is important to us. Please click here for our Privacy Policy which explains the purposes for which we will use your personal information and the ways in which we will handle and retain your information. It also explains the rights you have in relation to your information, and how to contact us with any queries or requests. 3rd Party Non-Solicitation Policy: By submitting candidates without having been formally assigned on and contracted for a specific job requisition by Avantor, or by failing to comply with the Avantor recruitment process, you forfeit any fee on the submitted candidates, regardless of your usual terms and conditions. Avantor works with a preferred supplier list and will take the initiative to engage with recruitment agencies based on its needs and will not be accepting any form of solicitation. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process, click the Apply button below to Login/Register. Benefits: Work From Home

TLNT1_IJ

  • Ireland

Compétences linguistiques

  • English
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