Director, Regulatory Affairs

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Fahrenheit IT
Analytical Skills, Development, Director, FDA, Manager, Materials, Medical Device, Project, Protocol, Recruiter, Research, Scientific
Full Time
Work from home not available Travel not required

Job Description

Full Description:

One of our leading clients, a U.S. biopharmaceutical company, focusing on early stage clinical development of oncology and immunology/inflammation is seeking an established Director/Senior Director of Regulatory Affairs; Director of Regulatory Affairs managing all regulatory aspects (Clinical, CMC) of clinical development of multiple innovative drugs in different therapeutic areas. Company is focusing on early stage clinical development of oncology and immunology/inflammation. We also have multiple opportunities with highly motivated leaders of Clinical Development Including Oncology & Non-Oncology Therapeutics located in Princeton, NJ office.

These opportunities are direct-hire roles. If you are interested in aligning with a highly regarded organization that values quality and integrity and fosters an environment where teamwork and professionalism thrive, then don't hesitate to contact Rose Chu, VP in Pharmaceutical & Biotech Services Group at #610-822-1256 for questions.

Company offer abundant opportunities for motivated pharmaceutical professionals to pursue their scientific/clinical interests, make an impact and maximize their growth potential. Please find the qualifications and requirements below. If you feel that this position is one that you are excited about and qualified for, please send over your most recent CV. We are always interested in talking to candidates for current AND future opportunities! ***Please respond directly at with your resume attached -WORD document***

Major Responsibilities

* Develop and implement global regulatory strategies for IND/NDA/BLA applications.

* Provide regulatory guidance and scientific advice to cross-functional international project teams to ensure early consideration of regulatory and clinical requirements, as well as alignment on regulatory plans and strategies.

* Interface with cross-functional teams (CMC, Nonclinical, Clinical) to define contributions of required documents for regulatory submissions.

* Collect, review and revise study reports and documentation to ensure high-quality preparation of applications (IND, CTA, BLA, NDA, etc.) in compliance with FDA and other global health authority requirements.

* Interact with regulatory agencies, coordinate the preparation of responses to questions and inquiries from FDA and other health authorities.

* Serve as primary liaison with regulatory authorities, including overseeing the writing of meeting materials, leading the preparation for meetings with regulatory agencies, and ensuring appropriate follow-up.

* Monitor and maintain all regulatory activities to ensure compliance with relevant regulatory requirements, including but not limited to, protocol and information amendments, clinical study reports (CSRs), pediatric study plans, annual reports and safety reports to support clinical development in the US, EU, Canada, and other countries as necessary.

* Ensure relevant US and international regulatory laws, regulations and guidance, as well as internal policies and procedures are followed to ensure regulatory compliance is maintained.


* Requires a Master's degree in life science or related discipline, PhD preferred.

* 10+ years of pharmaceutical industry experience required. At least 5 years of regulatory affairs with experience associated with global submissions.

* Experience with the research and development of oncology drugs is highly desirable.

* Excellent knowledge of global regulatory requirements and processes and filing experience (IND, CTA, NDA, BLA).

* Extensive experience working with CRO's.

* Strong verbal and written communication skills are essential. Ability to speak Chinese is a plus.

* Excellent organizational and analytical skills. Detail oriented and a great ability to support multiple projects in a timeline-driven environment.

As a well-funded biotech company, company pays highly competitive salaries and a comprehensive benefits package. Interested individuals are encouraged to contact or submit their CV to the following email address:

Search Terms: Director of Regulatory Affairs, Regulatory Affairs Director, Medical Director, Senior Medical Director, Executive Director, Sr. Director, Oncologist, Research & Development, biopharmaceutical, cell therapy, gene therapy, regenerative medicine, scientific leadership, Clinical Development, assessment of new drug targets, new technology, oncology, autoimmune, drug R&D projects, R&D strategies, managing drug discovery programs, preclinical and clinical development, research sites, research collaborations, research platforms, MD, drug discovery projects, Pharmaceutical industry and Oncology experience, PhD/MD/Post Doc, oncology, immunology, drug discovery, international pharmaceutical companies, biotech industries, drug discovery research, R& D Lead, Research & Development Head, Head of clinical research, Head of Oncology Research, Lead the development of clinical strategies

We appreciate your understanding, in that; we will only be able to respond to those inquiries who meet the stated requirements. To protect our client's interests, we will not be responding to inquiries that do not contain a CV/Resume. Finally, please include the position ID (rc-Director Reg. Affairs) in the subject line of your correspondence to ensure review.

Please forward your credentials in Word format through Indeed or call Rose Chu at 610-822-1256 for questions. Our clinical recruiter/manager will contact the qualified candidates IMMEDIATELY to set up interviews.

Rose Chu

Vice President - Pharmaceutical, CRO, Biotech, Medical Device

Global Employment Solutions/Fahrenheit IT

P (610)822-1256 | C (215)-317-2999 | F (610-668-5000) |

One Presidential Blvd. North, Suite 310, Bala Cynwyd, PA 19004

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ID: 164976

Company Information

With Fahrenheit IT you get national reach with access to an extensive business network and a wide range of resources from one company and you get the personal attention of a local business team. Your Fahrenheit IT team lives and works within your community, they know the market dynamics and stay connected to the top tech talent. Our services are focused on meeting the technical demands of today’s businesses head on. Recognizing that all of our clients have unique challenges, we work together to craft a solution to solve your immediate and long-term staffing challenges.
Dice Id : 10111360
Position Id : 164976

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