Regulatory Affairs Manager

4 semanas atrás

Lisboa, Portugal Meet Recruitment Limited Tempo inteiro

Global Regulatory Affairs Manager
We're currently seeking a Global Reg Affairs Manager for an award-winning pharma company specialising in OTC products. Overseeing the whole dossier process, working with license variations, acting as a submission specialist will all be core components of this role
The Regulatory Affairs Manager will be responsible for overseeing the regulatory process for products, from development to post-market approval. He/she will ensure compliance with applicable regulations and standards.
RESPONSIBILITIES
Preparation (compile and/or write the modules of an eCTD file, mainly Module 1 and 3), review and submission of regulatory documents throughout the product lifecycle (initial marketing authorisation submission, variations, notifications and renewals) to regulatory agencies to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
Preparation, review and submission of responses to regulatory agency inquiries
Monitor and set timelines for licence variations, notifications and renewal approvals
Ensure compliance with regulatory requirements and guidelines
Monitor and update regulatory documentation as necessary to keep company in compliance from a regulatory perspective
Participate in meetings with regulatory agencies as needed
Participate in meetings with manufacturers as needed
Advise manufacturers on regulatory requirements
Document and track regulatory submissions and regulatory authority approval
Is responsible for review, proof reading and approval of artwork of packaging materials to ensure compliance with regulatory requirements
Is responsible for the preparation of Summary of Product Characteristics, Patient Information Leaflets and labelling according to the Quality Review Documents (QRD) format
Collaborate with cross-functional teams including R&D, Quality, and Marketing to ensure that all regulatory requirements are met throughout the product lifecycle
Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products
Keep up to date with national and international legislation, guidelines
Maintains RA archives (electronically)
EXPERIENCE PROFILE
Scientific background is a must – master's degree in pharmaceutics, health care, life sciences or related fields preferred
5 + years of experience in a similar role, preferably in an international environment
Minimum of 5 years of experience in regulatory affairs within the pharma industry
A good knowledge and preferably experience with pharmaceutical development and validation of processes
Experience in developing and maintaining regulatory compliance documentation, including technical files, regulatory dossiers, and other relevant documentation
Experience in interacting with regulatory authorities
Excellent planning and time management skills
A good knowledge of relevant European guidelines, applicable legislation and regulations
Fluent communication skills in English (written and oral), also in Dutch is an asset
COMPETENCIES
Strong team player, with the ability to work effectively in team setting and interaction with people of different seniority and functional backgrounds
Ability to work independently and as part of a team
Ability to offer ideas and accept ideas of others
Highly ethical, honestly, reliability, accountability, loyalty
Ability to handle and enjoying complex and changing environments
Positive "can do" attitude
Ability to consistently meet deadlines, remain organized, adaptable and autonomous
Good communication and presentation skills
English language skills (spoken and written), Dutch is a bonus
Ability to work concurrently on projects, each with specific instructions that may differ from project to project
If this role sounds interesting to you, then please apply or reach out to ******

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