Regulatory Lead

**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, and also to direct and oversee the work of the country/local regulatory specialists on a per-project basis. The Regulatory Lead is a contact point for the client for matters related to study start-up/product approval requirements and 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.

**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 utilisation and 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.

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.

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

Fluent in written and spoken English. Additional language skills desirable

Computer literate

**Desirable Work Experience, Qualifications and Knowledge**:
Thorough understanding of regulatory agency and ethics committee requirements in at least one region/market

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

Ability and willingness to travel at least 35% of the time (international and domestic)

**Cmed Core Values and Guiding Principles**:
All Cmed employees are required to exhibit and demonstrate the Cmed ‘Core Values’.

**Client focus**: Satisfaction and Solutions

**Dependability**: Competence and Quality

**Trustworthy**: Open and Honest

**Innovative**: Approaches

**Winners**: Win-Win

All Cmed employees are required to follow Cmed’s Guiding Principles:
We care about our customers, but are not afraid to say no or disagree

We only take on projects within our abilities to perform well

We always aim to do the right thing and approach every situation with good intentions

We pursue responsible profit and responsible growth, and spend money sensibly, as if our own

We believe organisation, management, governance and control are positive, but bureaucracy and micro-management are negative

We love common sense

We are the enemy of mediocrity

We have a hunger for innovation and a thirst for ideas

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