EU Generalist
contractโขNamibia
About this role
This is a remote position.
From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com
We are currently seeking a dynamic and versatile professional to join our team as an EU Generalist. Below is a comprehensive job description outlining the responsibilities, qualifications, and expectations for this role:
Responsibilities:
Serve as a key point of contact for all matters related to European Union (EU) regulations, policies, and procedures across various functional areas within the organization.
Monitor and interpret EU regulations, directives, and guidelines applicable to pharmaceutical, biotechnology, and medical device products to ensure compliance and facilitate business operations.
Provide regulatory guidance and support for product development, registration, and commercialization activities in EU member states, including preparation and submission of regulatory applications (e.g., MAAs, variations, notifications).
Conduct regulatory assessments and gap analyses to identify compliance risks and develop strategies for addressing regulatory challenges and issues.
Collaborate with cross-functional teams, including regulatory affairs, clinical development, quality assurance, and market access, to ensure alignment on regulatory strategy and objectives for EU markets.
Support the preparation and coordination of regulatory submissions and interactions with EU regulatory authorities (e.g., EMA, national competent authorities), including participation in regulatory meetings and responses to inquiries.
Stay abreast of emerging regulatory trends, changes, and updates in the EU regulatory landscape and provide insights and recommendations to internal stakeholders.
Serve as a subject matter expert on EU regulatory requirements and processes, providing training and guidance to internal teams as needed.
Qualifications:
Bachelor's degree in life sciences, pharmacy, regulatory affairs, or related field; advanced degree preferred.
Minimum of 5 years of experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry, with a focus on EU regulations.
Deep understanding of EU regulatory requirements and procedures for pharmaceutical, biotechnology, and medical device products, including experience with centralized and decentralized procedures.
Proven track record of successful interactions with EU regulatory authorities, including preparation and submission of regulatory applications and participation in regulatory meetings.
Excellent communication and interpersonal skills, with the ability to effectively convey complex regulatory concepts and requirements to internal and external stakeholders.
Strong analytical and problem-solving abilities, with the ability to assess regulatory risks and develop strategies for compliance.
Regulatory affairs certification (RAC-EU) or relevant professional certification (e.g., TOPRA Diploma) preferred but not required.
Ability to work independently and collaboratively as part of a multidisciplinary team, with a commitment to delivering high-quality regulatory support and guidance to the organization.
This is an exciting opportunity for an EU regulatory affairs professional to make a significant impact on our organization's regulatory strategy and operations in the EU market. Competitive compensation packages are available.
Be part of our network of Subject Matter Experts.
EEO Employer:
Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact [email protected].
Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality.
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What you'll do
- Serve as a key point of contact for EU regulations and provide regulatory guidance for product development and commercialization activities. Collaborate with cross-functional teams to ensure alignment on regulatory strategy and stay updated on emerging regulatory trends.
About Pharmavise Corporation
โฆ๐๐ฑ๐๐๐ฅ๐ฅ๐๐ง๐๐ ๐ญ๐ก๐ซ๐จ๐ฎ๐ ๐ก ๐๐ฎ๐๐ฅ๐ข๐ญ๐ฒโฆ: ๐๐ก๐๐ซ๐ฆ๐๐ฏ๐ข๐ฌ๐, ๐ฒ๐จ๐ฎ๐ซ ๐ฌ๐ญ๐ซ๐๐ญ๐๐ ๐ข๐ ๐๐ข๐๐ ๐๐๐ข๐๐ง๐๐๐ฌ, ๐๐๐๐ฅ๐ญ๐ก๐๐๐ซ๐ ๐๐ง๐ ๐๐จ๐ฏ๐๐ซ๐ง๐ฆ๐๐ง๐ญ ๐ฌ๐จ๐ฅ๐ฎ๐ญ๐ข๐จ๐ง๐ฌ ๐ฉ๐๐ซ๐ญ๐ง๐๐ซ.
๐๐ฏ๐ผ๐๐ ๐๐ ๐๐ป๐ณ๐ผ๐ฟ๐บ๐ฎ๐๐ถ๐ผ๐ป:
We provide high-quality, cost-effective people and process solutions for your Quality, Regulatory, Engineering, Clinical, and Healthcare needs. Our company mantra ๐๐๐๐๐๐๐๐๐๐ ๐ญ๐ก๐ซ๐จ๐ฎ๐ ๐ก ๐๐๐๐๐๐๐. The safety and quality of the drugs and devices produced for patients are directly related to 2 things, ๐๐๐๐๐๐ ๐๐๐๐๐๐๐ ๐๐ง๐ ๐๐๐๐๐๐
๐๐๐ ๐๐๐๐๐๐. ๐๐ ๐๐๐ฅ๐ข๐ฏ๐๐ซ ๐๐จ๐ญ๐ก.
๐๐ข๐๐๐๐ซ๐๐ง๐ญ๐ข๐๐ญ๐จ๐ซ๐ฌ:
โ๐๐ข๐ ๐ก๐ฅ๐ฒ ๐๐ค๐ข๐ฅ๐ฅ๐๐ ๐๐๐๐ฆ: Our team of experienced consultants with distinct backgrounds in life sciences, including scientists, researchers, and regulatory experts. The quality and expertise of our team significantly impact our clientโs success.
โ๐๐ฉ๐๐๐ข๐๐ฅ๐ข๐ณ๐๐ ๐๐ฑ๐ฉ๐๐ซ๐ญ๐ข๐ฌ๐: We focus on specific niches within the life sciences, healthcare, and government sectors, such as pharmaceuticals, biotechnology, medical devices, regulatory affairs, medical research, and product development. This specialized expertise allows us to offer targeted and in-depth insights to our clients.
โ๐๐ฎ๐ฌ๐ญ๐จ๐ฆ๐ข๐ณ๐๐ ๐๐จ๐ฅ๐ฎ๐ญ๐ข๐จ๐ง๐ฌ: We offer tailored solutions that align with the specific requirements of each client, rather than one-size-fits-all approaches, demonstrating a commitment to meeting client needs. We do not require a long learning curve, which leads to a faster payback and a greater return on your investment.
๐ฃ๐ฒ๐ฟ๐ณ๐ผ๐ฟ๐บ๐ฎ๐ป๐ฐ๐ฒ ๐๐ถ๐๐๐ผ๐ฟ๐
Over 20 Technical Transfers and 30 product launches.
11 FDA remediations. Warning Letters and or Consent Decrees.
Cost savings and increased efficiency of over 10MM for clients
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Frequently Asked Questions
What does a EU Generalist do at Pharmavise Corporation?
As a EU Generalist at Pharmavise Corporation, you will: serve as a key point of contact for EU regulations and provide regulatory guidance for product development and commercialization activities. Collaborate with cross-functional teams to ensure alignment on regulatory strategy and stay updated on emerging regulatory trends..
Is the EU Generalist position at Pharmavise Corporation remote?
The EU Generalist position at Pharmavise Corporation is based in Namibia. Contact the company through Clera for specific work arrangement details.
How do I apply for the EU Generalist position at Pharmavise Corporation?
You can apply for the EU Generalist position at Pharmavise Corporation directly through Clera. Click the "Apply Now" button above to start your application. Clera's AI-powered platform will help match your profile with this opportunity and guide you through the application process.