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Regulatory Affairs Manager
Il y a 3 mois
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 daniel.chitra@peoplewithchemistry.com
