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.
The Senior Associate will provide an overview of the responsibilities of the position by providing a summary of the most important aspects and duties of the position.
- Lead Local Regulatory Responsible (LRR) oversees LRRs to ensure effective deicion making and mooth operations and acts as the first escalation point for LRR challenges.
- Local Regulatory Responsible focuses on local regulatory requirements and Health Authority national engagements.
- The key interactions are with local external stakeholders e.g. Health Authorities, Local industry association(s), In Market commercial counterpart and Regional Regulatory Lead (RRL) counterparts in respective GRA Regional team
Experience:
- 5+ years of (local) regulatory knowledge and experience in a regulatory authority facing role; i.e. comprehensive understanding of regional and global regulatory requirements, guidelines and processes
- Leadership experience
- In-depth expertise on local health authority management
- Project management skills and leadership skills; i.e. proven experience in managing e.g., regulatory submissions, timelines and cross-functional teams to ensure timely and successful product registrations and compliance
- Experience in managing ComOps Stakeholders: matching influencing style to stakeholders to maximise impact and effectiveness of GRA expertise, proactively identifying opportunities to influence stakeholders on business critical decisions and employing a systematic approach to influence key internal stakeholders based on business needs and objectives
- Experience in successfully dealing with rapid change
Competence:
- Fluent in local language and English, oral and written
- Relevant bachelor’s degree or equivalent secondary education e.g. natural sciences (biology, chemistry with pharmacological focus)
- Expert MS Office skills
- Excellent organizational, time management and interpersonal skills in a global environment.
- Ability to work successfully in a complex global matrix organization.
- Proven ability to work effectively both independently and in a team.
- The expertise, determination and courage to resolve or escalate issues as appropriate.
Top Skills
What We Do
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.
