Regulatory Affairs Consultant Safety & Labelling (home or office based)
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Monthly Salary:
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
When our values align theres no limit to what we can achieve.
At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.
Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.
We are seeking an experienced Regulatory Affairs Consultant Safety & Labelling to develop and execute artwork strategies for our global product this critical role you will ensure comprehensive oversight throughout the product lifecycle while serving as the primary liaison between Regulatory Affairs and various stakeholders.
The role can be home or office based in various European locations.
Role Responsibilities:
Conduct and deliver high quality on time safety labelling regulatory activities including compliant management of all internal tools and client systems;
Author administrative and regulatory documents/deliverables and collaborate with project SMEs and client stakeholders to prepare submission packages;
Full management of safety labelling submissions (i.e. planning submission package compilation RIMS maintenance RtQ preparation Spontaneous HA queries etc.);
Act as main GRA point of contact for local regulatory and other stakeholders
Tracking and management of all EU Product Information alignment with QRD requirements and ability to manage EU linguistic review readability testing and translation activities.
Supporting regulatory inputs into Periodic Safety Update Reports (PSUR) and potential impact on labelling
Participation in change control process for safety labelling update
Skills and Experience required for the role:
Bachelors Degree in a Scientific or Technical Discipline
Knowledge of EU regulatory requirements for medicinal product labelling
Familiarity with the Company Core Datasheet (CCDS) and its implementation into labelling and artworks
Understanding of Safety Signal Management and the impact of confirmed safety signals on labelling
Excellent communication and stakeholder management skills;
Strong organizational and time management skills;
Strong problem-solving skills;
Coordinate all assigned activities;
Proactive and efficient work ethic;
Strong oral and written communication skills with proven ability to work efficiently as part of a team;
Strong interpersonal skills;
Fluent in English written and spoken
Required Experience:
Contract
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Parexel is in the business of improving the world’s health. We do this by providing a suite of biopharmaceutical services that help clients across the globe transform scientific discoveries into new treatments. From clinical trials to regulatory, consulting, and market access, our the ... View more
