EU Generalist

Lachman Consultant Services, Inc; España; On-site; PHP 4,747,071 - 14,241,213; Part time

Job summary

A leading consulting firm is seeking per diem pharmaceutical consultants proficient in English and one other European language. Ideal candidates should have a B.S. in life sciences or engineering, with over 10 years of experience in regulatory compliance, quality assurance, and FDA regulations. Responsibilities include performing GMP audits, managing regulatory compliance evaluations, and contributing to the drug approval process. Strong communication and project management skills are essential.

Qualifications

• Must effectively communicate in English and one other European language.
• 10 years of related experience with detailed knowledge of FDA regulations.

Responsibilities

• Perform GMP/GLP audits covering laboratory procedures.
• Manage regulatory inspections and compliance evaluations.
• Lead projects and meet crucial timelines.

Skills

Regulatory compliance expertise

Quality Systems / Quality Assurance

Superb written and oral communication skills

Project management

Training

Education

B.S. in life sciences or engineering

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.