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Regulatory Affairs Manager(remote-based)

Employer
Hobson Prior
Location
Maryland, USA, Gaithersburg
Salary
£98421.16 - £123026.45 per annum + 15% bonus
Start date
19 Mar 2021
Closing date
14 Apr 2021

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Senior Management

Job Details

An excellent opportunity has arisen for a Regulatory Affairs Manager to be involved in improving the quality of life for people all over the world, giving them the opportunity to live a fuller and healthier lifestyle. You will join a global specialty biopharmaceutical organisation where you will be required to work remotely.

Please note that to be considered for this role you must have the right to work in this location.


Job Responsibilities:

  • Recognise new concepts for analysing data and promoting awareness of Regulatory Affairs strategies.
  • You will oversee the management of procedures and best practices; in consultation with SME's, draft procedures and best practices and ensure such documents are accurate and effective and are catalogued appropriately in the documentation system.
  • To understand and communicate impact of Industry and Agency changes relevant to RA and be a catalyst for innovative process change for improved efficiency.
  • Assist the Regulatory Affairs team in training and educating team members on procedural changes.
  • Liaise with Operational Excellence team in applying OE Author and review internal work instructions and standard operating procedures (SOPs) pertaining to RA activities (electronic or paper), QC, and records management
  • Lead Regulatory initiatives aimed at improving internal regulatory standards, systems and procedures
  • Supports budgeting and forecasting activities, including possibly managing expenditure activities related to approved vendor contracts.
  • Support the organization with training needs; position will work with SME's to ensure proper training programs exist for technical areas but is not expected to be the SME trainer.
  • Co-operates with cross-functional teams to ensure overall process meets the needs of internal and external stakeholders.

Key Skills:

  • Robust written and verbal communication skills.
  • Robust interpersonal skills.
  • Careful attention to detail and accuracy required.

Requirements:

  • Bachelor's degree or equivalent is essential.
  • A minimum of 5-10 years of experience preferred in Regulatory Affairs or Quality Assurance; manager experience is preferred.
  • Experience in global submissions, document management, biological and vaccine products preferred.
  • Previous experience with Operational Excellence initiatives.
  • Extensive knowledge of MS Word, Project, PowerPoint, Excel, and other MS Office applications and Adobe Acrobat.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.



Company

Providing recruitment solutions across the life sciences industry

Hobson Prior is a leading specialist life sciences recruiter focused on finding and placing outstanding candidates across Europe and the Asia Pacific. We work proactively and with integrity, communicate in a professional and honest manner and invest time to understand and match the exact requirements of our clients and candidates.

Our highly selective clients trust us to source and secure interim and permanent candidates who’ll make a real difference to the success of their business. Our candidates, the best in the industry, often choose to work with us exclusively because we offer the best opportunities in their specialist field.

Representing who we are and what we stand for, our values influence the way we serve our clients and candidates and the way we interact with each other.

We identified them collaboratively – as a team – and so feel 100% invested in them. Together, we think they provide the best possible outcomes all who work with us.

Professional
Our standards are set high. We work to a rigorous set of processes to ensure that our conduct is professional, ethical and delivered with integrity at all times.

Dedicated
We are dedicated to finding the very best solutions for our clients and candidates, always going the extra mile to deliver measureable value.

Experienced
We are guided by our experience and knowledge to provide the best possible service and support to our candidates, clients and colleagues. Our approach is consultative and collaborative.

Specialist
We focus solely on our chosen market, developing expert consultants who know their industry in depth and specialise within it.

Proactive
We find great candidates, developing relationships with them regardless of whether they are actively looking. This means we are able to provide both candidates and clients with unique opportunities.

Ambitious
Driven by results, we have plans to expand across different global regions and markets and have confidence in our ability to grow successfully through our core focus.

Company info
Website
Telephone
01892 612 612
Location
Wellington Gate
7-9 Church Rd
Tunbridge Wells
TN1 1HT
United Kingdom

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