Ethypharm is a specialty pharmaceutical company with prominent products in targeted Central Nervous System (CNS) indications, notably severe pain, and opioid dependency, as well as a wide range of high-quality injectable medicines for hospitals and emergency situations.
Our Spanish commercial affiliate is based in Madrid with two manufacturing sites located in Bernedo and Casarrubios, which offer a wide range of injectable forms, including flexible plastic bags, liquid vials, lyophilized vials and ampoules.
We are looking for a Regulatory Affairs Manager who will be responsible for leading the Spanish regulatory team and ensuring compliance with national and international pharmaceutical regulations. This role oversees the day-to-day regulatory submission activities for the Spanish market, including new registrations in line with strategic plans and NPI timelines, variations, renewals, tenders, PPQRs, and customer/commercial queries.
Key responsibilities include performing regulatory impact assessments, maintaining relevant trackers, and managing core dossier preparation, license maintenance, and approvals. The role also involves proactively interfacing with health authorities to facilitate rapid responses to RFIs and drive license approvals. Additionally, the Regulatory Affairs Manager collaborates with cross-functional stakeholders and project teams to coordinate and procure essential documentation and samples required for regulatory submissions.
Main Responsabilities and Duties
Teamwork
Must be collaborative and able to influence change
Must be flexible and strive for continuous improvement
Able to work in a global environment with multiple and diverse cross-functional teams
and subject matter experts/ corporate partners
Cross-culturally competent and customer service oriented
Must have good Time-Management skills
Able to work independently and proactively search out solutions to challenges, by obtaining data from multiple and diverse resources, required to support global regulatory submissions
Require minimal supervision for day to day activities and project oversight/ execution
Demonstrate initiative by providinginput with respect to continuous improvement opportunities for tools, systems and processes
Able to identify risk, with mitigations and resolutions to be presented to cross-functional
teams.
Planning/ Organisation
Able to construct, support and manage high visibility project plans in support of assigned projects
Able to prioritise work load and meet established goals and timelines for established regulatory strategy and plan.
Must track, coordinate and procure required documentation for global regulatory
submissions.
Decision Making/ Impact
Able to identify risk/ root cause and provide options for resolution to regulatory affairs team accordingly with minimal impact on registration timelines.
Analytical skills required to interpret regulatory data in order to be able to verify data accuracy and search out the appropriate information.
Identify areas for improvement to systems, project plans and processes.
Make quality decisions sometimes with incomplete information, whilst able to deal with uncertainty/risks and grasping the essence of the issue.
Additional responsabilities
Responsible for supporting all products as assigned this may include geographic expansion, new product registrations and marketed products
Identify the gaps between available data and data required to prepare the modules for the regulatory dossier in eCTD format especially module 2 and 3.
Prepare modules all the Module 1 for Regulatory submissions, and by working with cross functional team / partners Module 2, 3, 4 & 5 for the regulatory dossier in eCTD format as required.
Co-ordinate and / or prepare review, submit and subsequently manage applications to Regulatory Authorities in a timely manner. This will include:
Marketing authorisation applications
Variations and renewal requests for existing authorisations
Answers to questions and post registration / approval submissions
Meeting packages for scientific advice and protocol assistance
Preparation of product labelling texts and leaflets
Utilize regulatory expertise to review, develop and deliver core labeling documents such as Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL) to support submissions to the Regulatory Authorities across regions, requesting input from others when appropriate.
Interact with other cross-functional roles in the delivery and management of labeling text through the appropriate processes and systems.
Responsible for translating the labeling documents in local language as per submission requirements
Communicate, plan, prioritize and deliver labeling documents according to company targets and submission requirements.
Also ensure compliance of core labeling documents such as SmPC and PIL to reference safety information and highlight the gap to get medical advice. Also, to do appropriate actions to bring labeling documents in line with reference safety information.
Ensure that any additional data requested by Regulatory Authorities is generated at minimal cost
Liaise with other departments in the company in order to obtain all the necessary information required for regulatory submissions Liaise with international regulatory authorities for advice and guidance on how to progress submissions
Liaise with other partners in order to obtain relevant information for regulatory submissions
Provide regulatory advice and guidance to colleagues in other departments, e.g. Marketing, Quality Assurance, Production, etc.
Maintenance of the licences
Collect, review, organise, assemble and check reports and summaries
Keep up to date with legislation and regulations and provide regulatory input to internal and external business partners
Responsible for providing information, and data on regulatory and other activities to the Regulatory Affairs Director
Profile
University degree and 5 year os experience in similar role
Pharmacy background
Knowledge:
CRT modules
Labelling requirements
submission of variations and renewals
Written and oral communication skills, both in spanish and english