Regulatory Affairs Manager

As Regulatory Affairs Manager (RAM), you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.

You will be dedicated resource to one of our clients, be embedded in their working environment, systems and processes. You will be engaged in a wide range of interesting and challenging tasks.

You will be partnering with one of the worlds premier Biopharmaceutical companies. Working across a vast portfolio of medicines and vaccines this company has, over centuries created a strong heritage of delivering innovative treatments and preventive medicines globally.

**What you will be doing**:

- Project manages submission related operational aspects. Creates and manages project plans for regulatory projects using input from key stakeholders. Leads and manages cross functional submission teams from authoring to dispatch/project goal delivery. Identifies operational risks with projects/submissions, implements mitigation plans, and manages issues to closure.
- Represents the regulatory project and submission management (RPSM) group in cross-functional planning to develop global regulatory submission and execution plans in line with the client’s needs and regulatory team goals.
- Partners with document providers to project manage the timely receipt of submission ready documents for inclusion in local/regional/global dossiers.
- Communicates external agency submission standards and internal business submission processes to ensure compliance and efficiency in the delivery of submission.
- Ensures that company is aware and responsive to external guidelines, regulations, changes in the marketplace and other information relating to local/regional/global regulatory project and submission management.

**What you need**:

- Undergraduate degree or international equivalent in clinical, science, or healthrelated field from an accredited institution; health care professional licensure, i.e., Pharmacy, Life Sciences, Business or Information Technology.
- Relevant experience executing of CTA and Central Ethics process regional/globally
- Proven technical aptitude and ability to learn and use software, regulations and quality standards.
- Equivalent combination of education, training, and relevant experience may be considered in place of the education and experience stated above. All employees must read, write and speak fluent English and host country language.

**Why ICON**:
At ICON, we embrace new perspectives and empower our people to write their own paths forward. We are a culturally diverse company with varied skills, perspectives & backgrounds working together across 40 countries.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.

At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.