Website Lachman Consultants
Lachman Consultants is seeking Per Diem Pharmaceutical Consultants who are proficient in both the English and one other European language (reading, writing, and speaking), and 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:
- Various dosage forms including oral solid, liquid, and other non-sterile, as well as sterile, dosage forms
- Quality systems / quality assurance / quality standards
- GMPs / GLPs / guidances and regulations
- Quality control
- Laboratory QA
- Data Integrity
- Facilities and Equipment
- Risk assessment process / application
- Standard Operating Procedure development / reviews
- Pre-marketing requirements, activities, regulations and guidances
- Post-market reviews, considerations, safety reporting, regulations and guidances
- Computer Systems validation
- Regulatory Affairs Experience (experience with DMF’s and ANDA’s for generic APIs and drug products is preferable)
➢ 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.
➢ Consultants must have a minimum of a Bachelor’s degree in life sciences, engineering or related field, as well as 10 years’ related experience, and detailed knowledge of current FDA regulations and expectations.
If you meet all the qualifications, please submit your full chronological resume via the Lachman website or to firstname.lastname@example.org.