Regulatory Submission Specialist
- Employer
- Warman O’Brien
- Location
- United States
- Salary
- Competitive Annual Salary plus Bonus and Benefits
- Start date
- 20 Sep 2022
- Closing date
- 20 Oct 2022
View more
- Discipline
- Regulatory Affairs
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
Job Details
An experienced Submission Specialist is required to join a growing global biotech on a permanent basis. This is a fully remote role based in the US/Canada (East Coast only).
Within this role, you will be responsible for supporting the Global Regulatory Affairs team for planning and organising submissions worldwide, with emphasis on US & EU submissions. This position will be reporting to the Submission Manager in Regulatory Operations while supporting the Global Regulatory Affairs teams.
What you will be doing:
- Conducting and facilitating cross-functional kick-off meetings
- Liaising with internal and external stakeholders to drive filing teams forward through planning
- Coordinating, participating, and facilitating filing team meetings to ensure health authority requirements are met, documents finalised/approved and delivered to publishers on time to meet project and health authority timelines.
- Supporting the entire portfolio of products from early development through life cycle maintenance.
- Creating and managing the Submission Content Plans (SCP), timelines and responsibility matrices through cross-functional discussions, and tracks submission deliverables to maintain the target filing date
- Ensuring documents are compliant with internal standards, ICH, and other guidelines for incorporation into eCTD submissions, using Veeva Vault RIM (SCP) functionality
- Acting as Subject Matter Expert (SME) for specific Reg. Ops tasks, such as building electronic submissions using Veeva Vault SCP and using validated processes and adhering to SOPs and Working Instruction documents
What you can bring to the role:
- Bachelor’s degree with 4 years or 8 years experience in relevant functions in the Pharmaceutical/Biotechnology Industry, or equivalent
- Project management skills and ability to oversee and prioritize multiple activities across sites for multiple customers.
- Service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment.
- Highly experienced in Microsoft Project, Vault RIM with emphasis on Submission Content Plan functionality, Extedo eCTDManager publishing tool experience is preferable.
What you get in return:
- A permanent remote role offering a competitive annual salary
- The opportunity to join a growing business and to work with industry experts
Company
Warman O’Brien is a global specialist Life Sciences Recruitment Partner across the UK, Europe, USA and APAC. We recruit top talent across a number of functional areas including:
- Biometrics
- Data Sciences
- Quality Assurance
- Regulatory Affairs
- Clinical Research
- Discovery Sciences
- C-Suite
- Medical Affairs
We cover contract and permanent vacancies, executive search, and SOW for companies across the pharmaceutical industry.
Find out more on our website warmanobrien.com/
- Website
- https://warmanobrien.com/
- Telephone
- +44 (0) 2033255075
- Location
-
Floor 5
Regal House
70 LONDON ROAD
Twickenham
TW1 3QS
United Kingdom
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