Manager, Regulatory Services

il y a 1 semaine

Paris e, France Certara Temps plein

**Job Overview**:
**Responsibilities**:

- Proactively and effectively communicate to all stakeholders to drive seamless professional development and optimal resource utilization
- Provide administrative direction, provide solutions to obstacles of success, consistently encourage employees to learn new skills, guide professional development and recognize performance
- Take steps to identify employee skills and work to strengthen those skills while developing new skills
- Strive to hire top talent and reduce undesirable turnover and learn to identify factors that help engage staff
- Understand the value of coaching as a key tool to support personal development
- Monitor performance of work product and administrative responsibilities and address non-compliance
- Proactively alert senior management of issues requiring intervention, communication, or additional support
- Conduct effective and regular 1:1 meetings and perform expedient follow-up (as applicable) and performance assessment

**Education, Experience, Training, and Knowledge**:

- BS degree in life sciences or equivalent
- 2+ years of regulatory writing or editing experience within the nonclinical, clinical, CMC, or drug safety related space
- Basic knowledge of drug development and regulatory requirements and process
- Proven leadership ability working with a team of high-level, high-intensity writers, editors, publishers and project managers at a variety of experience levels

**Skills & Abilities**:

- Ability to make independent decisions with the company and staff’s best interests in mind
- Ability to earn the respect of other company leaders
- Demonstrated ability to manage and oversee projects and/or resourcing for projects
- Ability to provide high-quality customer service and follow-through on all assignments
- Professional, personable demeanor
- Strong interest in a writing/editing role but with a stronger interest in leading others with those interests
- Show basic understanding of communication theory (listening, summarizing, questioning etc.) and effective presentation of internal and external content
- Approachable and supportive and willing to listen and understand employee concerns
- Recognize value in sharing information; thinks about others and considers available sources of input to accomplish objectives
- Responds to requests to work in a collaborative manner by providing input when required
- Understands impact of own work or behavior on colleagues / other areas of the business, respects views that are different from own

**OTHER INFORMATION**:
**Number of Employees Supervised**:6

**Percentage of Travel Required**:10%

LI-HM1

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