Cmc Author, Senior Regulatory Affairs Specialist

**Overview**:
**Senior Regulatory Affairs Specialist (CMC author) - Homebased in UK, Poland, Spain or Germany**

As a Senior Regulatory Affairs Specialist (CMC) you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

In this role, you will serve as a regulatory CMC author/writer, supporting a leading global pharmaceutical company.

Responsible for global CMC regulatory strategies and activities for a large Pharma portfolio through clinical development, market launch and product lifecycle management.

**Responsibilities**:
**What you will be doing**:

- Managing routine CMC authoring and submission activities for an assigned products or
product portfolio to assure the preparation of high quality and compliant global
regulatory submission.
- Maintains regulatory CMC dossier templates in alignment with current ICH and
relevant regional regulatory requirements and standards
Maintains a core source file management system to support all global plasma CMC
submission activities.
- Keeps current on global global submission requirements, standards and formats.
- Assures an effective collaboration with Global Regulatory Affairs CMC Strategists,
Global Manufacturing and Global Quality SMEs for the timely preparation and review
of regulatory submission documentation.
- Acts as liaison with relevant regulatory operations teams (e.g, Publishing)
Supports the development of efficient submission authoring and preparation
procedures to assure timely completion of submission packages per business and
regulatory timelines.
- Helps maintain relevant submission-related systems and trackers and assures that
global CMC regulatory submission documentation is consistent in terms of content and
alignes with the global dossier templates.
- Identifies country-specific submission requirements.
- Collaborates with Global Regulatory CMC Strategists to define detailed scope of
submissions.
- Coordinates document review sessions to collate comments and corrections of drafted
documents and prepares the documents for final approval for timely submission.

**Qualifications**:
**You are**:

- A minimum of an undergraduate degree in a life-sciences discipline (or be a licensed healthcare professional).
- The role requires a demonstrated experience in global pharmaceutical/biotechnological drug development and knowledge of the global regulatory CMC environment.
- Experience in authoring and managing components of regulatory submissions.
- Knowledge of global regulatory requirements.
- Ability to use precedent and previous experience to develop innovative and flexible approaches to achieve development and commercial goals.

**What ICON can offer you**:
Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being
- Life assurance
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others