Description:

An American Multinational Contract Research Organization is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Every day we perform better because of how we work together, as one team, each the best at what we do. We bring a wide range of talented experts together across a wide range of business-critical services that support our business. Every role within Corporate is vital to furthering our vision of Shortening the Distance from Lab to Life®.

Job Summary:
An American Multinational Contract Research Organization is looking for a detail-oriented regulatory attorney to join its Legal team. The successful candidate will be a self-starter with excellent judgment and significant experience advising clients on laws, regulations, and industry standards governing clinical development and commercialization of pharmaceutical products.

Job Responsibilities:

Responsible for providing legal regulatory advice and counsel on global regulatory and clinical development matters.
Assists Head of Legal Regulatory with the strategy and implementation of the Legal Regulatory function in alignment with departmental and functional goals and company strategy.
Provides legal and regulatory advice to Corporate Quality and the clinical business on quality-related issues, regulatory authority inspections, client and internal audits.
Provides legal support to Dispute Resolution team on litigation and pre-litigation matters as appropriate.
Advises internal teams on the application of drug and device laws and regulations, as well as Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP) and Good Pharmacoepidemiology Practice (GPP) as well as Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) as they relate to clinical research.
Provides legal support for communications with regulatory agencies.
Provides legal support for compliance and quality investigations as appropriate.
Assists Head of Legal Regulatory in advising the business on new and modified service offerings.
Supports regulatory due diligence in connection with potential M&A or other business transactions.
Keeps abreast of legislative and regulatory changes that may affect the company and its customers.
Advises on regulatory and Quality Assurance commitments in clinical and commercial agreements.
Works collaboratively across the Legal department, including the Company's global team of regional-based attorneys, in providing legal regulatory advice, building consensus on process improvements, and driving corporate legal projects to completion.
Supports An American Multinational Contract Research Organization ‘Mission, Vision and Values.'

Qualifications:
What we are looking for:

Fully qualified lawyer.
8+ years of experience advising on legal and regulatory matters in the pharmaceutical research and development space.
Broad understanding of the clinical trials regulatory framework, with awareness of key differences across international jurisdictions.
Strong working knowledge of GxP requirements applicable to clinical research, with a particular focus on GCP and GVP.
Ability to communicate clearly, concisely, and professionally with all levels of management regarding complex regulatory issues.
Experience working in a healthcare or life sciences company, such as a CRO, biotech, or pharmaceutical drug development company.
Ability to work independently while being able to contribute successfully to cross-functional teams.
Independent judgment, attention to detail, a desire to learn, and an ability to take on and prioritize a wide variety of complex matters in a fast-paced environment.
Can-do attitude, ability to work under pressure and to manage the expectations of clients.
Creative problem-solving ability with a focus on achieving client-friendly solutions while managing company risk.
Sense of humour is a plus.