Beschrijving van de functie
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)
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.
Jouw profiel
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.
Taalvaardigheden
- Nederlands (troef)
- Begrijpen : Vaardig - (C1)
- Schrijven : Vaardig - (C1)
- Lezen : Vaardig - (C1)
- Spreken : Vaardig - (C1)