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Regulatory Affairs Specialist II
Ref No.: 18-06575
Location: Waltham, Massachusetts
Job Title:Regulatory Affairs Specialist II
Duration: 4 Month Plus
Location: Waltham, MA
Job ID: 8125172

Job Description:
In the liable business area pertaining to compliance monitoring of timelines for
processing/regulatory reporting of safety reports, the primary function of the role is to :
• Contribute to the development, production and maintenance of the appropriate
tracking and compliance tools, reports, plans, tasks and activities pertaining to the
management of the GPE compliance management system.
• Perform investigation of deviations and monitoring of Corrective actions &
preventive actions (CAPA) relating to non compliance issues and findings and propose
appropriate long-term strategies to line management.
• Perform compliance analysis and Contribute to development, production and
maintenance of adequate reporting methods to the hierarchy to detect and monitor any
significant compliance deviations to the company quality standards and/or regulatory
• Track and communicate on compliance
• Ensure tasks and activities are performed according to the work instructions,
procedures and Policies in place.
• Contributes as an author or a reviewer to GPE Quality Documents
developed within
the Company and relating to compliance monitoring.
• Interface with internal and external stakeholders and ensure that the appropriate
contact points are established with the other groups (within Quality, Training &
Compliance or outside) to respond and address gaps or compliance issues that need
resolution by team specialists.
• Support Affiliates on compliance matters as required
• Support the conduct of PV audits/regulatory inspections
• Participate to the Development of compliance programs and quality tools to
enhance GPE global quality and adherence to SOPS and Regulations.
• Escalate issues / problems to management

Good understanding of Corporate Pharmacovigilance Duties and Rules in a
Pharmaceutical Company
- Good knowledge of business area and interactions with strong regulatory
environment and ability to identify and understand proactively the interactions
necessary for achieving Business Goals and Objectives
- Ability to identify proactively and anticipate risk of non-compliance in a complex
- Knowledge of compliance international Regulations and ICH environment foundations
- Good analytical/judgment capabilities to understand/analyse/synthesize and
- Project Management Abilities
- Able to manage both time and priority constraints and to manage multiple priorities
- Attention to details
- Take intitiative and autonomous
- Able to lead TCs and meetings
- Computer literacy, work in database(s)
- Proven ability to work in international environment and cross-functional team, with
good interpersonal skills
assertiveness / team spirit / caching skills
- Fluent in English

Scientific background: usually baccalaureate +5 years (Pharm D., Health/Life
science...) with at least two years experience in Pharmacovigilance / Pharmaceutical
environment & safety in an international environment.
In depth understanding of international pharmacovigilance requirements/updates in
particular EU/FDA requirements/international guidelines, e.g. ICH/CIOMS, Clinical
development methodology and knowledge of Clinical Trial guidelines (GCP) and
An additional degree in pharmaceutical regulatory environment, or in business
management or in quality management would be much appreciated.
Creativity to propose/create/supervise appropriate tools to support business activity
Writing quality documents
Project/time management/training