Ethypharm · 1 week ago
Senior Regulatory Affairs Officer - Maternity Cover
Jupiter, FL
Full-time
Onsite
Senior Level
5+ years expEthypharm is a leading mid-sized global pharmaceutical company that manufactures and provides essential drugs, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine. The Senior Regulatory Affairs Officer will be responsible for managing regulatory efforts for EU and UK products, particularly in the context of post-Brexit regulations, ensuring compliance and supporting the expansion of the product portfolio into new markets.
Health CareLife ScienceManufacturingPharmaceutical
Responsibilities
Portfolio Management: Specialise in managing regulatory affairs for EU products within Ethypharm portfolio, ensuring adherence to relevant regulations and standards
Gap Analysis: Conduct thorough assessments of Marketing Authorisation (MA) versus manufacturing documents to identify and address any discrepancies
New MA Applications: Lead the preparation and submission of new Marketing Authorisation applications in the EU through various routes including National, Mutual Recognition, and Decentralised Procedures
Geographical Expansion: Drive the expansion of our current portfolio into other EU markets by navigating regulatory requirements and compliance standards
RA Support for New Product Development: Provide regulatory guidance and support to the New Product Development team to ensure compliance with EU regulations from the outset
In-licensing Support: Offer regulatory support for in-licensing activities, ensuring smooth integration of acquired products into our portfolio
MA Compliance Maintenance: Ensure ongoing compliance and maintenance of Marketing Authorisations for the assigned portfolio of In-house manufacturing and Contract Manufacturing Organisations and oversee compliance for the team
Safety Variations: Ensure safety variations e.g. updating in line with reference products, PRAC recommendations, and Internal Safety updates for the assigned portfolio and oversee the Team submitting their assigned safety variations
Change Control Management: Manage regulatory change controls, Corrective and Preventive Actions (CAPAs), and deviations, with familiarity with the SAP system preferred
Implementation of Patient Information Leaflets (PILs) and Mock-ups: Oversee the comprehensive execution of PILs and mock-ups implementation, including finalising all procedural aspects, managing relevant national phases in each member state, collaborating with the artwork team and local affiliates/partners to create PIL mock-ups and artwork, and coordinating all necessary processes to ensure the timely implementation of new PIL mock-ups and artwork
Qualification
Required
Regulatory experience in the pharmaceutical industry minimum 5 years
Life science degree
Experience of working in a global matrix organisation and collaborating at all levels including external authorities and partners
National, Mutual Recognition and Decentralised Procedures
A philosophy that sees Regulatory Affairs as a value-adding, integral part of the business, rather than a bureaucratic 'necessary' function
Good commercial sense, combined with an absolute commitment to high regulatory standards
Excellent planning, analytical and decision-making abilities, combined with strategic vision and a pragmatic, results-orientation whilst maintaining attention to detail
Communicate effectively in both written and oral form
Must be flexible and strive for continuous improvement
Preferred
Familiarity with the SAP system preferred
Company
Ethypharm
Ethypharm designs, formulates, develops, manufactures, and markets pharmaceutical products for the treatment of pains and addictions.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2016-05-06Acquired
Leadership Team
Bertrand Deluard
President and CEO
Cecile Paillous
Corporate Quality V.P.
Recent News
2024-12-05
Company data provided by crunchbase