EU Generalist
Remote
RemoteContractSmall
ContractSmall
Job Summary
Serve as the key point of contact for all EU regulatory matters, monitoring and interpreting directives to ensure compliance across pharmaceutical, biotechnology, and medical device sectors. Provide guidance for product development, registration, and commercialization by preparing and submitting regulatory applications to authorities like the EMA. Conduct gap analyses to identify compliance risks and collaborate with cross-functional teams to align regulatory strategy for EU markets. Stay abreast of emerging trends to provide insights to internal stakeholders and serve as a subject matter expert offering training and guidance.
Required Qualifications
- Bachelor's degree in life sciences, pharmacy, regulatory affairs, or related field
- Minimum of 5 years of experience in regulatory affairs within the pharmaceutical, biotechnology, or medical device industry
- Focus on EU regulations
- Deep understanding of EU regulatory requirements and procedures for pharmaceutical, biotechnology, and medical device products
- Experience with centralized and decentralized procedures
- Proven track record of successful interactions with EU regulatory authorities
- Experience with preparation and submission of regulatory applications
- Participation in regulatory meetings
- Excellent communication and interpersonal skills
- Ability to effectively convey complex regulatory concepts and requirements to internal and external stakeholders
- Strong analytical and problem-solving abilities
- Ability to assess regulatory risks
- Ability to develop strategies for compliance
- Ability to work independently
- Ability to work collaboratively as part of a multidisciplinary team
- Commitment to delivering high-quality regulatory support and guidance to the organization
Desired Qualifications
- Advanced degree
- Regulatory affairs certification (RAC-EU)
- Relevant professional certification (e.g., TOPRA Diploma)
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