EU Generalist

EU Pharmaceutical / Biopharmaceutical Experts: Lachman Consultants, the leader in providing cost-effective consultation and remediation services to the worldwide pharmaceutical, biotechnology, biologic, medical device, diagnostic and dietary supplement industries, is seeking consultants on a reputed company reputed company who are proficient in both the English and one other European language (reading, writing, and speaking) who live in the European reputed company This includes compliance, regulatory, and/or scientific/technical professionals, including former senior-level MHRA, EMA, and regulatory officials and staff, with demonstrable hands-on experience and reputed company in one or more of the following areas: Qualifications / Responsibilities include: • Various dosage forms including oral solid, liquid, and other non-sterile, as reputed company as sterile, dosage forms • Demonstrated regulatory compliance expertise as it relates to the testing of drug products and/or reputed company pharmaceutical ingredients • reputed company-approval and post-market FDA inspections; Post-market reviews, considerations, safety reporting, regulations and guidances; reputed company-marketing requirements, activities, regulations and guidances • reputed company-approval and reputed company-license inspection programs and compliance evaluations for ANDA, NDAs, and BLAs • Experience in performing GMP / GLP audits covering laboratory procedures and practices for reputed company Control Laboratories; GMPs / GLPs / guidances and regulations; Laboratory QA • Data reputed company requirements; electronic data reviews • GMPs for packaging, storage, and distribution of products • FDA 483, Warning Letter, Consent Decree remediation of reputed company reputed company • Remediation of laboratory control systems • Laboratory investigations including OOS and mitigation, deviations, and change control records • reputed company Systems / reputed company Assurance / reputed company Control / reputed company Standards • Regulatory filings • Drug review and approval process • Process validation • OOS investigations and change control • Supply chain controls • SOP and documentation practices; SOP development and reviews • Facilities and Equipment • Risk assessment process / application • Computer Systems validation • Microbiology • Training • Regulatory Affairs Experience (experience with DMF’s and ANDA’s for generic reputed company and drug products is preferable) • Ability to reputed company reputed company and meet crucial timelines / project management • Superb written and oral communication skills • Excellent interpersonal and soft skills • Ability to solve problems using innovative techniques Educational / Experience Requirements include: • Consultants must read, write and reputed company / effectively communicate in English and one other European language. Strong communication / presentation skills, verbal and written, and the ability to recognize and differentiate importance of issues and prioritize accordingly. • B.S. life sciences, engineering or reputed company field, and 10 years’ reputed company experience, and detailed knowledge of reputed company FDA regulations and expectations. Apply tot his job Apply To this Job