Regulatory Affairs Associate
il y a 2 semaines
Global Regulatory Affairs Associate
We're currently seeking a Global Reg Affairs Associate for an award-winning pharma company specialising in OTC products Preparing submissions of license variations, assisting in preparation of regulatory documents, acting as a submission specialist will all be core components of this role
The Regulatory Affairs Associate will be responsible for assisting in the preparation and submission of regulatory documents to regulatory agencies. He/she will ensure compliance with applicable regulations and standards.
RESPONSIBILITIES
- Assist with the preparation and submission of regulatory documents to regulatory agencies
- Assist in the preparation and submission of responses to regulatory agency inquiries
- Prepare submissions of licence variations, notifications and renewals to strict deadlines
- 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
- Provide on-going regulatory support to the Regulatory Affairs Manager(s) and to project teams to ensure regulatory concerns are planned and accounted for and the relevant data are generated to meet project objectives
- 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
- 2 + years of experience in a similar role, preferably in an international environment
- 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.
- Personality: determined, persuasive, assertive, and communicative
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
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