Regulatory Affairs Manager

Regulatory Affairs Manager

Office: U.S. based - Remote worker

ICON is currently recruiting for a Regulatory Affairs Manager to join our Strategic Regulatory & Safety Consultancy group that forms part of a wider Commercialization and Outcomes group. Our regulatory consulting team serves clients around the globe-from biotech startups to big pharma-as well as the research firms that serve them. We're headed by industry leaders who bring more than three decades of regulatory affairs experience to your projects. They, in turn, are backed by an unsurpassed team of more than 100 professionals and staff.

The Manager, Regulatory Affairs has responsibility to provide comprehensive regulatory services for clients requiring support for registration and maintenance activities in the respective regions for pharmaceuticals, biologics, medical devices and other product types. This role involves leading the preparation, filing and maintenance of regulatory submissions as well as management of clients.

• Effectively-prepare regulatory files and provide support for maintenance activities in adherence with applicable legislation, and guidelines facilitating approvals and continued client compliance
• Prepares FDA NDSs, SNDSs, CTAs and post-approval submissions
• Updates Module 2 clinical and non-clinical summaries for filing
• Manages and ensures maintenance of a positive and productive liaison with internal and external contacts, including regulatory agencies, clients, and related institutions.
• Lead/attend formal interactions (face-to-face meetings, teleconferences, etc.) with clients and, possibly, government agencies.
• Develops initial or alternative regulatory strategies consulting with their manager and other resources within the organization as needed. Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.
• Responsible for managing project workflow including prioritizing project objectives, and establishing timeframes for projects with clients. Responsible for overseeing progress and completion of projects with project team members, ensuring timeframes and deadlines are met.
• Lead, participate in and support project teams related to regional filings and maintenance activities across a range of product types.
• Effectively prioritize and complete multiple projects within established timeframes.
• Proactively monitors for new regulatory requirements and shares key learnings.
• Train or mentor others to build team expertise across various product types.
• This role will prepare quotations for projects that may cross multiple service areas within the company and manage projects within budget preparing change orders as needed.
• Proactively improve business processes and tools to facilitate provision of core services.

Required experience:

• Minimum of BS in Life Science, healthcare, engineering preferred
• Minimum of 6-8 years of relevant experience, i.e. pharmaceutical drug with regulatory experience in the local environment.
• Experienced and knowledgeable with FDA regulations, guidelines and submission preparation
• Experienced with Medical writing / updating module 2 clinical and non-clinical summaries
• Awareness/knowledge of international guidelines as appropriate, such as GMP, GCP, GxP, ICH
• Ability to convey thoughts in a clear, concise and accurate manner; use appropriate regulatory medical and scientific nomenclature; listen carefully and ask questions when necessary to ensure understanding; proactively share experience/expertise with others
• Attention to detail: identifies and resolves discrepancies across various source documents including published and unpublished documents; note and resolve errors in written documentation
• Planning and organizing ability: plans work effectively to meet goals and ensure timely completion of assignments; manages time effectively, using a system for completing work; consistently meets timelines and works within budget; proactively discusses workload issues with manager.

Why join us?

Ongoing development is vital to us, and as a Regulatory Affairs Manager you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success!

ICON is an equal opportunity employer and committed to providing a workplace free of any discrimination or harassment.

EOE race/color/religion/sex/sexual orientation/gender identity/disability/vet/national origin