The Responsible Person Consultant (Rest of World Release Advisory) is responsible for providing expert guidance on global batch release and distribution requirements outside the EU and US within a regulated GMP environment. The role focuses on advising internal quality teams on market-specific release expectations, supporting the assessment of regulatory information from regional counterparts, and acting as a key subject matter expert for Rest of World compliance. Additionally, the position involves close collaboration with QA, operational quality, and US-based stakeholders to strengthen international release processes and ensure compliant product distribution.
Non-Negotiable Skills, Qualifications, and Experience
- WO level of education
- Degree in Life Sciences, Pharmacy, or a related scientific discipline
- Strong knowledge of GMP
- Experience as a Responsible Person, QA lead, or comparable quality/release professional
- Strong experience with batch release and distribution processes
- Proven knowledge of Rest of World release requirements outside the EU and US
- Experience working in an international, regulated pharmaceutical environment
- Ability to work in an advisory / consultative capacity
Desirable Skills, Qualifications, and Experience
- Experience with release requirements across regions such as LATAM, MENA, APAC, Canada, Russia, and Israel
- Experience supporting commercial drug product distribution in global markets
- Experience interacting with internal and external stakeholders across multiple regions
- Experience working with US-based teams and stakeholders
- Ability to assess and challenge regulatory input from local market counterparts
- Availability for part-time support of approximately 6–8 hours per week
- Flexibility to support meetings in late afternoon / early evening CET
What the Assignment Offers
- Initial part-time consulting assignment of approximately 6–8 hours per week
- Fully remote working model
- Expected long-term need, with an initial outlook of at least 1 year subject to budget approval
- Opportunity to act as a strategic subject matter expert in an international quality environment
- Exposure to global release and distribution topics across multiple international markets
Interested in discussing this opportunity confidentially?
? m.vansloun@panda-int.com
? +31 20 204 4502