Key Facts

Remote From:

Freelance

Senior (5-10 years)

English

Hard Skills

Business Partnering Regulatory Compliance Regulatory Compliance Regulatory Compliance Auditing Escalation Management Health And Safety Standards Regulatory Compliance Risk Mitigation Corrective And Preventive Action (CAPA) +3 more

Other Skills

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Training And Development
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Communication
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Interpersonal Communications
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Cultural Sensitivity
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Empathy
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Relationship Building

Roles & Responsibilities

Ideally 5+ years of experience in Regulatory Affairs, oversight, governance or compliance roles within pharmaceutical, biotechnology or healthcare industry
Partner management experience with proven ability to manage relationships with third-party vendors
Ability to work in a highly matrixed organization and establish successful cross-functional working relationships across diverse disciplines; interpersonal awareness and cultural sensitivity

Requirements:

Oversee partner management and third-party activities end-to-end, ensuring regulatory compliance with laws and company standards; monitor partner performance against agreed metrics and address deviations promptly
Conduct periodic assessments of partners for compliance with local requirements and quality standards; implement corrective actions and develop risk mitigation strategies and controls
Serve as primary contact for escalations and issue resolution related to partner activities and maintain positive relationships with local partners
Stay updated on local regulatory requirements, guidelines, and industry trends; communicate changes to GRA/local teams and participate in policy activities with industry groups and trade associations

Parexel

Pharmaceuticals

About Parexel

Parexel is among the world’s largest clinical research organizations (CROs), providing the full range of Phase I to IV clinical development services to help life-saving treatments reach patients faster. Leveraging the breadth of our clinical, regulatory and therapeutic expertise, our team of more than 21,000 global professionals collaborates with biopharmaceutical leaders, emerging innovators and sites to design and deliver clinical trials with patients in mind, increasing access and participation to make clinical research a care option for anyone, anywhere. Our depth of industry knowledge and strong track record gained over the past 40 years is moving the industry forward and advancing clinical research in healthcare’s most complex areas, while our innovation ecosystem offers the best solutions to make every phase of the clinical trial process more efficient. With the people, insight and focus on operational excellence, we work With HeartTM every day to treat patients with dignity and continuously learn from their experiences, so every trial makes a difference. For more information, visit parexel.com. Community Guidelines Because Parexel’s social media channels are open to the general public and employees, we are not responsible for views expressed other than our own. However, we do not tolerate posts that are: • Abusive, harassing or threatening to others. • Defamatory, offensive, obscene, vulgar or depicting violence. • Hateful targeting by race/ethnicity, age, color, creed, religion, gender, sexual preference or orientation, nationality or political beliefs. • Sexually explicit or pornographic. • Fraudulent, deceptive, libelous, misleading or unlawful. • Referencing criminal or illegal activity. • Spamming. We reserve the right to remove any comments that do not adhere to our guidelines as well as report users who violate the rules of our page.

Company type: XLarge

Industry: Pharmaceuticals

Founded: 2018

Company size: 10001

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Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

Regulatory Partner Responsible (RPR) focuses on partner management and oversight of partner activities. The key interactions are local partners, In Market commercial counterpart and Regional Regulatory Lead (RRL) counterparts in respective GRA Regional team.

Main Responsibilities and Accountabilities

Strategy (execution) & (partner) management

Ensure oversight on key processes and ensure framework is in place to manage third-party activities E2E ensuring compliance with regulations and company standards; monitor partner performance against agreed-upon metrics and standards, addressing any deviations or deficiencies promptly.
Conduct periodic assessments of partners to ensure compliance with local requirements and quality standards, implement corrective actions as necessary; develop risk mitigation strategies and implement controls to minimize risks associated with partner activities. Act as point of contact for escalations and issue resolution related to partner activities.
Stay updated on local regulatory requirements, guidelines, and industry trends to ensure compliance with evolving regulations and communicate to GRA and local team; participating in policy activities with industry groups and trade associations.
Support regional regulatory TA teams within GRA, for efficient planning and submission preparation according to local requirements and business needs.
Keep internal databases up to date with local activity and ensure compliance KPIs are adequately kept on track.
Act as primary interface with local partners representing the company's regulatory interests and fostering positive relationships and ensure that partner, who is acting on CSL behalf, has the appropriate interactions with Has.
Monitor training effectiveness and compliance, ensure proper trainings are developed and in place, providing support and resources as needed to address gaps and improve performance.

Experience

Ideally 5+ years of experience in Regulatory Affairs, oversight, governance or compliance roles within pharmaceutical, biotechnology or healthcare industry.
Partner management experience: proven experience in managing relationships with third-party vendors.
Ability to work in a highly matrixed organization and to establish successful cross-functional working relationships with people in a wide variety of disciplines and backgrounds, be interpersonally aware and culturally sensitive.