Generalist

Job Description

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.

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.

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 info@pharmavise.com .

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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Requirements

Last updated : 2024-11-06