Job Description
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 per diem basis who are proficient in both the English and one other European language (reading, writing, and speaking) who live in the European Union 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 skill in one or more of the following areas:
- Qualifications / Responsibilities include:
- Various dosage forms including oral solid, liquid, and other non-sterile, as well as sterile, dosage forms
- Demonstrated regulatory compliance expertise as it relates to the testing of drug products and/or active pharmaceutical ingredients
- Pre-approval and post-market FDA inspections; Post-market reviews, considerations, safety reporting, regulations and guidances; Pre-marketing requirements, activities, regulations and guidances
- Pre-approval and pre-license inspection programs and compliance evaluations for ANDA, NDAs, and BLAs
- Experience in performing GMP / GLP audits covering laboratory procedures and practices for Quality Control Laboratories; GMPs / GLPs / guidances and regulations; Laboratory QA
- Data integrity requirements; electronic data reviews
- GMPs for packaging, storage, and distribution of products
- FDA 483, Warning Letter, Consent Decree remediation of complex matters
- Remediation of laboratory control systems
- Laboratory investigations including OOS and mitigation, deviations, and change control records
- Quality Systems / Quality Assurance / Quality Control / Quality 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 APIs and drug products is preferable)
- Ability to lead projects 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 speak / 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 related field, and 10 years’ related experience, and detailed knowledge of current FDA regulations and expectations.
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