Senior Regulatory Affairs

Description:
**Location**: Machelen Area, Belgium - Home based

**Schedule**: Full Time, Permanent

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for an international CRO can bring? Our team says it's the best of both worlds.

TalentSource Life Sciences (the sponsor-dedicated division of CROMSOURCE), is searching for a
- **Senior Regulatory Affairs** to join one of our clients, one of the most innovative pharmaceutical companies in the world.

**Main Job Tasks and Responsibilities**:

- Provides strategic guidance to Cardiovascular & Specialty Solutions (CSS) related to regulatory requirements and develops recommendations pertinent to the Franchise in accordance with regulations and relevant guidelines
- Ensures the timely execution of regulatory implementation activities and associated projects
- Provides clear and timely communication of new and changing requirements to the Franchise regulatory teams
- Educates Franchise Associates on EU requirements and integrates those requirements into Franchise procedures
- Organizes and maintains reporting schedules, trackers, and systems
- Develops and sustains relationships with Research Associate affiliates, contributing to the development and execution of local strategy. This includes planning, prioritization, and preparation of responses to regulatory agencies' questions and other correspondence
- Drives consistency across all businesses within Cardiovascular & Specialty Solutions (CSS) and across MedTech for technical documentation creation and adherence to procedures
- Supports the creation of technical documentation for products within the portfolio to ensure continued knowledge, understanding of challenges, and process improvements throughout the program
- Supports the project plan and schedule to ensure all regulatory interdependencies are understood and accounted for in the overall schedule
- Develops and maintains constructive and cooperative working relationships with business functions in the organization
- Identifies and facilitates continuous improvement activities
- Represents Cardiovascular & Specialty Solutions in various internal forums
- Develops solutions to a variety of problems of extreme complexity in which data analysis requires an evaluation of intangible variables
- Writes, reviews, and revises company SOPs as required, recommending adjustments to processes to improve efficiency or align with compliance requirements
- Responsible for communicating business-related issues or opportunities to the o next management level
- Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety, and Environmental practices and that all resources needed to do so are available and in good condition
- Responsible for ensuring personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures
- Performs other duties assigned as needed

**Education and Experience**:

- University degree in Science, Engineering, Technical or Biomedical field or Law (or equivalent degree with adequate experience)
- 6-8 years of experience in Regulatory Affairs or other related disciplines in the medical device or pharmaceutical industries
- Regulatory experience in Chemistry, manufacturing, and controls (CMC) with post-approval variation dossiers for small molecules worldwide preferred
- 2-4 years of experience in Regulatory Affairs
- Knowledge of global/worldwide regulatory guidelines and regulations is preferred

**Skills**:

- Good knowledge of medical device regulatory requirements in the EU
- Ability to work effectively in a highly matrixed organization
- Ability to work autonomously
- Project Management Skills
- Strategic thinking and ability to partner and influence key stakeholder's
- Highly skilled in establishing partnerships with Regional and Franchise colleagues
- Strong communication, influencing, and presentation skills
- Strong results-orientated and sense of urgency
- Strong ability to build constructive and cooperative working relationships
- Excellent written and verbal communications skills in English (required)

**The Application Process**

**Who will you be working for?**

**_
About CROMSOURCE _**
- CROMSOURCE is a family-owned international, full-service Contract Research Organisation that, since 1994, has been supporting our clients with outstanding clinical research and staffing solutions services. The successful growth of CROMSOURCE has been achieved by putting high quality and client focus at the heart of everything we do.

**_
Our Company Ethos_**
- Our employees are the most valuable company asset. We value our resources and ensure they work in a friendly, family environment so they are able to develop their skills and talents. Human Resources is the fulcrum around which all CROMSOURCE activities are built and close management and training is the core instrument to develop and ma