[Hiring] Global Regulatory Affairs Manager @MMS

Role Description

We are looking for a full-time employee, remotely based within the UK.

• Maintains a strong in-depth knowledge of applicable regulations and ICH guidances as well as regional specific guidelines where they exist.
• Expertise with MS Office, Adobe Acrobat and SharePoint applications, SAS viewer and eCTD viewer.
• Expertise tracking, reporting of central submission/approval progress, and archiving of all regulatory activity in applicable MMS systems.
• Provides strategic input and technical guidance on regulatory requirements to project teams including oversight for the publishing of regulatory submissions according to ICH guidance.
• Monitors the impact of changing regulations on submission strategies and updates, participating in implementation as applicable.
• Oversees the completeness of project deliverables by conducting expert reviews prior to release to client.
• Reviews, develops, gives advice on, and/or writes regulatory documents, meeting requests and regulatory responses for Scientific Advice, CTAs, and/or MAA.
• Serves as the lead strategist for the original marketing application.
• Obtains and maintains Clinical Trial Authorizations and Marketing Application approvals including Response to Questions (RTQs).
• Understands the eCTD submission process and can answer questions for internal and external stakeholders.
• Knowledge and advisement of expedited approval applications, orphan drug designation, meeting requests, and briefing docs and regulatory responses.
• Acts as POC for regulatory submissions and ex-US Competent Authorities and coordinates across multiple regions for investigative and marketing applications.
• Manages regional label negotiation activities.
• Advises on annual reports and coordinates multiple annual reports; also should have experience with post-approval safety updates.
• Advises on harmonization of US and Global submissions.
• Coordinates with clinical CROs, local Authorized Agents and third party vendors on global regulatory submissions.
• Can optimize a clinical trial submission or marketing application submission strategy based on regional knowledge.
• Follows processes related to project management as appropriate for medical writing projects.
• Manages project risks and timeline.
• Effectively manages multiple projects and delegates as needed to complete projects on time.
• Notifies project manager and line manager of changes to scope and timeline.
• Provides oversight into the creation/maintenance of project plans and input for timelines.
• Participates and guides sponsor in meeting prep specifically for Scientific Advice, pre-submission meetings, marketing applications, and advisory committees.
• Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
• Evaluates and communicates impact of relevant regional regulations, guidance, current regulatory environment and competitor labelling.
• Monitors impact of changing regulations on submission strategies and updates internal and external stakeholders.

Qualifications

• Minimum of 5 years’ experience in Regulatory Strategy or similar field required.
• Expert knowledge of scientific principles and concepts.
• Reputation as emerging leader in field with sustained performance and accomplishment.
• Proficiency with MS Office applications.
• Hands-on experience with clinical trial and pharmaceutical development preferred.
• Good communication skills and willingness to work with others to clearly understand needs and solve problems.
• Excellent problem-solving skills.
• Good organizational and communication skills.
• Familiarity with current ISO 9001 and ISO 27001 standards preferred.
• Familiarity with 21 CFR Part 11, EMA, MHRA, and GCP requirements.
• Basic understanding of CROs and scientific and clinical data/terminology, and the drug development process.

Requirements

• Please consider your application unsuccessful if we do not reach out to you within 14 days of your submission.