Senior Manager Regulatory Affairs
TA Business Partner
- Full Service Division
About the role
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Sr Regulatory Affairs Manager
Raleigh/Durham or Remote role
At ICON, it's our people that set us apart.
As a global provider of drug development solutions, our work is serious business. But that doesn't mean you can't have fun while you do it. With our vision to be the partner of choice in drug development, we hire only the best and brightest in the industry. Are you one of them?
We are looking for passionate, resilient, and inspiring individuals to join our team. As the Sr Regulatory Affairs Manager, you will represent the Regulatory Affairs function on project teams and client meetings to provide regulatory guidance and strategy.
The role
Job Description Summary
- Participate in provision of Regulatory expertise in strategic drug development across multiple areas.
- Take part in preparation of strategic development and submission plans.
- Be involved in the regulatory affairs activities across the ICON portfolio and be an expert and advisor to ICON clients (externally and Internally)
- Be a trusted partner - represent the Regulatory Affairs Department in business development activities and generate new business opportunities
- Contribute to at least two of the following areas: Interactions with Regulatory agencies, early phase consulting, Development Planning (PDP/RDP/CDP), Scientific/Agency advise, orphan drugs/pediatric development, medical devices, Reg Intelligence, due diligence, strategic CT support/GCP compliance, biologlcal/blotech/biosimilars, small company support (incl. SOPs development etc.)
- As Regulatory Expert, build effective teams and Involve junior members of the team into more complex regulatory issues. Mentor and train across function to support the wider Regulatory Department.
What you need
- Minimum of a Bachelor's degree in Regulatory/Life Sciences
- Minimum of 8-10 years of Regulatory experience in Pharma, Biotech, or related industry
- Knowledge of IND/NDA/BLA requirements
- Sound knowledge of the life cycle of a drug development program
Why join us?
Ongoing development is vital to us, and as the Sr Regulatory Affairs Manager, you will have the opportunity to progress your career, with the potential to move into other related areas to enhance your skill set. Our benefits package is competitive, our scope is international and we genuinely care about our people and their success.
Benefits of Working in ICON :
Other than working with a great team of smart and energetic people, we also offer a very competitive benefits package. This varies from country to country so a dedicated recruiter will discuss this with you at interview stage.
We care about our people as they are the key to our success. We provide an open and friendly work environment where we empower people and provide them with opportunities to develop their long term career.
ICON is an equal opportunity employer - M/F/D/V and committed to providing a workplace free of any discrimination or harassment.
A better career. A better world. A better you.
Our people are our greatest strength, are the core of our culture and the driving force behind our success. Throughout all levels of the company, our people have a drive to succeed and a passion that ensures what we do, we do well. We help you build exciting and rewarding careers, deliver results to help bring life-changing medicine and devices to market and maintain ICON’s success as an industry leader. See all locations Read more
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