Quality Assurance & Regulatory Affairs Specialist - Temporary position
Core
Ensuring products are managed, released, stored, and distributed in accordance with Good Distribution Practices (GDP) and regulatory requirements; organizing regulatory information and compliance programs for Marketing Authorization.
Role type
Quality Assurance & Regulatory Affairs Specialist
Builds
Compliance programs for Marketing Authorization; regulatory applications for health authorities; internal SOPs database.
Domain
Pharmaceutical industry (reproductive and women's health, gastroenterology, urology)
Deliverable
client delivery
Required skills
Quality Systems management, regulatory requirements knowledge, SAP management, eCTD structure preparation, EU-wide legal framework awareness, SOP management, regulatory application compilation, labelling support, deficiency letter coordination, competent authority follow-up.
Preferred skills
Postgraduate Degree or Masters in Quality and Regulatory Affairs, English proficiency.
Responsibilities
Ensure effective and robust Quality systems are in place to comply with regulations; manage routine deviations, complaints, and coordinate significant investigations; provide support for audits and regulatory agencies; conduct change requests and support process modification change controls; manage internal SOPs system and maintain SOPs database; prepare and review SOPs for regulatory and quality assurance procedures; implement and maintain GDP training programs; compile and manage regulatory applications for health authorities; provide labelling support and maintain SPC updates; coordinate revision and preparation of deficiency letters from Authorities; follow up with Competent Authorities and vendors on regulatory activities; ensure regulatory database is up to date for projects in the region.
Seniority
Mid-level specialist (2-3 years experience)
