Regulatory Lead

2 weeks ago

Horsham, United Kingdom Cmed Full time

**Core Accountabilities**:
The role of the Regulatory Lead is to provide input and coordinate the input of others, e.g., country/local regulatory specialists, into study start-up/regulatory strategy/feasibility for regions on a per-project basis, to complete regulatory submissions, direct and oversee the work of the country/local regulatory specialists on a per-project basis. The Regulatory Lead is a contact point for all client matters related to the regulatory aspects of study start-up/product approval requirements, therefore the Regulatory Lead must be able to communicate issues effectively to the client, clinical team and Project Leader. The Regulatory Lead is accountable for ensuring that all project regulatory activities follow the relevant Cmed and regulatory guidelines and procedures and that startup/regulatory tracking systems are updated on time and correctly reflect the status of assigned projects/deliverables. The Regulatory Lead must be able to manage multiple start-up/regulatory projects globally.

This role is to be homebased anywhere in the UK/EU.

**Principal Responsibilities**:
Regulatory Project Management

Understands contractual obligations and the scope of work.

Proactively recognises any changes in scope and ensures timely completion of change orders.

Secures global regulatory resource as required per project.

Communicates effectively with, sets expectations, directs, and oversees the work of these regulatory resources.

Manages utilization, productivity and proactively resolves any issues.

Manages projects in adherence with Cmed SOPs, ICH-GCP, ISO, and other applicable guidelines and regulations.

Communicates progress, challenges, risks, issues, actions and decisions in the manner and timings agreed in the applicable Operational Plan(s).

Attends client and team meetings, including kick-off, as directed; develops and presents start-up/regulatory slide content.

Regulatory Affairs

Develops and executes regulatory strategy per project.

Contributes to regulatory operational plan and timeline development; proactively drives the achievement or betterment of the standards and timelines therein.

Provides regulatory review and/or input into essential documents, including but not limited to: protocol, investigator’s brochure, and participant informed consent documents.

Coordinates regulatory/start up activities as required, including RA/EC query resolution, management of document translations, and quality review of site document packets.

Maintains accurate metrics of planned and completed regulatory deliverables.

Responsible for leading interactions with the concerned Regulatory Agencies, and where appropriate, concerned ethics committees, globally.

Non-billable Activities

Participates in business development including consulting, sales and marketing support, and proposal and budget development.

Supports bid defense meetings as required.

Engages with and leads initiatives to drive process improvement.

Prepares and delivers departmental trainings, as required.

Communicates effectively with other members of Regulatory team, Clinical team, Project managers and other personnel.

Manages time effectively to ensure that deadlines are met and adhered to.

Able to prioritise tasks and manage conflicting deadlines.

Additional

The above job description in no way states or implies these duties are the only duties performed by this employee. The incumbent is expected to perform other related duties necessary for the effective operation of the department and company.

The Company reserves the right to change or alter any of the above duties and responsibilities according to the operational needs of the department and Company.

**Essential Work Experience, Qualifications and Knowledge**:
Background in medicine, nursing, pharmacy, life science or other relevant discipline with appropriate experience

Meets all proficiency requirements for Regulatory Lead and exceeds those for Regulatory Specialist/Associate levels

Thorough understanding of regulatory agency and ethics committee requirements in at least one region/market and experience making submissions.

Experience within Oncology.

Fluent in written and spoken English.

Confident and well spoken, with the ability to talk to clients and develop potential business relationships

Understanding of ICH, ISO, GCP, GMP and other relevant regulations and guidelines for the conduct of clinical trials and maintenance of marketing authorisations related to pharmaceuticals, biologics, advanced therapies, medical devices, and combination products

Computer literate

**Desirable Work Experience, Qualifications and Knowledge**:
Experience in multiple therapeutic areas

Understanding of multiple regions

Additional language skills desirable

Experience talking directly to Health Authorities and/or Ethics Committees

Experience in sales, bid defenses and/or proposal preparation

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