Regulatory Affairs Associate
Proclinical are recruiting for a Regulatory Affairs Associate to join a pharmaceutical organisation on a contract basis located in the Northwest region of the UK.
- Assist with the product registration and upkeep of allocated product application rendering to the business standards of regulatory compliance.
- Help across the group for allocated non-drug project roles & accountabilities such as a main point of contact for external partners.
- Provide contributions to regulatory expertise and information into pertinent systems and databases preserving the data precision and update of information for the group and pertinent database platforms.
- Uphold documentation and records management in regulatory information management systems such as Veeva Vault rendering to outlined standards and procedures as requested by RAMs and Global Regulatory Execution teams.
- Guarantee that documentation is available to proposal ready standards/house style, conduct QA/QC checks and specific writing tasks.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Familiarity working within a pharmaceutical organisation.
- Acquaintance with regulatory/medical/technical.
- Commercial and product consciousness.
- Expertise on regulatory proposal, compilation, publishing and approval procedures, standards, systems and tools.
- Influencing and communication skills.
- Computer literacy.
- An organised individual with a focus on delivery and outcomes.
- Project planning abilities.
- Interpersonal and networking capabilities.
- Works well independently as well as in a team.
- A proactive individual with the ability to resolve issues.
- A constant improvement attitude.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall on firstname.lastname@example.org
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.