Job Postings

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Position

Lead advertising & promotion activities. - Manage activities and communication are consistent with USPI and are in compliance with applicable laws, guidelines and Dompé policies; - Represent the Regulatory Affairs at PRC (Product Review Committee) and be responsible to revise, approve and submit materials for Dompé’s breakthrough therapy, the first-ever ophthalmic biologic product for patients suffering from a rare eye disease; - Direct the regulatory review of non-promotional scientific information, and external communication materials, including media information - Improve the strategies for FDA promotional submission, working with both US and HQ team - Support senior director regulatory affairs for BLA maintenance activities such as submission of PAS, CBE-30, Annual Report, Distribution Report etc. - Maintain current awareness of evolving regulation and interpretation, working closely north America regulatory affairs leader.

As a lead member of the regulatory affairs team, you will provide timely and valued regulatory support by owning the following tasks with minimal supervision: *Develop regulatory strategies based on client target market(s) *Review all documentation provided by client in preparation of product application to ensure compliance to standards, guidance documents, etc. and ensure most accurate submission to minimize RAI and/or RTA notifications. *Prepare regulatory submissions for global markets, submit to agencies and gain approval. *Conduct research and interface with quality systems and clinical affairs staff as required in support of product application and approval.

For further information or to apply, please contact Brooke Hamby at [email protected]

As a Regulatory Affairs Consultant you will work closely with an amazing team on a large, dedicated enterprise client partnership and provide regulatory strategy and oversight to a large portfolio for this client. You will ensure regulatory strategies are incorporated into regulatory submission documents and such documents are written and managed to team/project expectations and conform to the regulatory and company standards.

JobID: 73268BR

Parexel currently has an excellent opportunity for a Regulatory Project Leader/Senior Consultant with previous experience in Regulatory Affairs and past experience managing quality, on-time regulatory applications and filings. This Regionally Home Based position is part of our growing Regulatory Consulting Services Team and offers an amazing opportunity to join an industry leader in a field that continues to see tremendous growth and opportunity!

JobID: 63853BR

Are you a Nonclinical professional with a flair for Regulatory Writing? If so, we have a great home-based opportunity to join Parexel's highly esteemed Regulatory Consulting Services (RCS) team as a Senior Consultant. Our RCS Team provides clients with the strategies and services around defining and executing the most efficient path to obtaining regulatory approval. If so, we have a great home-based opportunity to join Parexel's highly esteemed Regulatory Consulting Services (RCS) team as a Senior Consultant. Our RCS Team provides clients with the strategies and services around defining and executing the most efficient path to obtaining regulatory approval. If so, we have a great home-based opportunity to join Parexel's highly esteemed Regulatory Consulting Services (RCS) team as a Senior Consultant. Our RCS Team provides clients with the strategies and services around defining and executing the most efficient path to obtaining regulatory approval.

JobID: 64496BR

Parexel’s incredible Regulatory Consulting team is currently seeking a Combination Product expert to join the team This is an amazing opportunity for an individual who is looking to partner with our clients in the very early stages of product development, use their expertise to help our clients develop their strategies, guide them along the regulatory pathway, and maintain post approval technical files.

JobID: 72379BR

Excellent opportunity for an experienced CMC Regulatory Affairs professional to bring your talent, excellent communication skills, strong writing experience, and CMC expertise to Parexel Consulting as a Senior / Regulatory Affairs Consultant! This is tremendous opportunity to gain exposure to novel technologies and gain tremendous exposure from clinical trials to post approval, to maintenance, and everything in between!

JobID: 74433BR

Parexel currently has an excellent opportunity for a Regulatory Affairs Consultant / Project Manager with previous experience managing small/mid-sized projects at the IND/NDA/BLA maintenance stage coupled with previous experience representing clients as a US Agent.

JobID: 71128BR

Are you an experienced Regulatory Publisher who is looking to combine your publishing expertise with your passion for delivering on time quality submissions? Who is looking for an opportunity to partner with a client with innovative therapies and provide oversight to their submissions? Who is looking for an opportunity work from home? Who has superior interpersonal skills and enjoys establishing and maintaining internal and external relationships? Who is savvy with Veeva or Insight Publisher? And is looking for an opportunity work alongside some of the Industry’s best? If you answered ‘yes’ to these questions, Parexel Consulting's growing Team has an excellent opportunity for you!

JobID: 73368BR

If you are passionate about labeling, have a passion for Regulatory Affairs, and are looking for an opportunity to work with an amazing team, then Parexel's Consulting has the perfect opportunity for you!

JobID: 66545BR

Job Overview: To provide regulatory and quality support to select clinical research projects involving investigational or marketed drugs, devices, biologics, or new medical procedures. To provide strategic regulatory guidance and information to projects; to acquire pertinent regulatory information from agencies and organizations; to support regulatory agency interactions, communications, and submissions; and to review project regulatory documentation to ensure compliance with applicable regulatory regulations and guidelines.

JobID: R1193249

This role is critical to lead the global Regulatory Affairs team requiring broad management and leadership skills across several billable areas. This involves recruiting a knowledgeable individual to lead multiple job areas with the ability to influence others to accept IQVIA practices and Biotech approaches on sponsor studies. Successful candidate should possess over 10 years' relevant experience (at minimum) gained from deep domain knowledge acquired from covering Clinical/Development & Strategy - Scientific Advice meetings with the Regulatory Authorities, across numerous Therapeutic Areas. Orphan Drugs/Rare Diseases experience desirable. The successful candidate needs to be strong in Regulatory Affairs Strategy, Tactics, and Implementation; possess working knowledge of Regulatory Intelligence; and spectrum of experiences supporting clients and taking products through Early and Late Phase, through to successful Registrations and Post marketing across Therapeutic Areas.

JobID: R1231195

This position offers a unique opportunity for experienced medical writers to work in a fast-paced environment with highly competitive compensation. 3D Communications is a market leader in regulatory preparation services for pharmaceutical and medical device companies seeking product approval in a wide range of therapeutic areas. 3D project teams collaborate with clients to develop clear and compelling scientific narratives in preparation for regulatory submissions, formal FDA and EMA meetings, CHMP oral explanations, and advisory committee meetings. 3D medical writers develop documents that capture the scientific and clinical history of the product while communicating the messages supporting approval. The medical writer collaborates with the rest of the 3D and client team to align the written materials with the other key project deliverables to drive a successful preparation and ultimately a successful regulatory outcome.

  The UNC Lineberger Comprehensive Cancer Center (LCCC) oversees and coordinates oncology clinical trial research for the UNC School of Medicine and UNC Cancer Care. The UNC Lineberger Sponsored Clinical Research team is primarily responsible for the clinical development, regulatory strategic management and FDA interactions for these LCCC sponsored trials. This position will provide strategic and tactical leadership to UNC investigators in support of their interdisciplinary drug/biologic clinical and translational protocol development and regulatory submissions. This position will collaborate in writing, editing, producing and reviewing oncology clinical trials protocols. This individual will aid in the authoring of LOIs (letters of intent) and development of grants to support these clinical and translational protocols. The individual will aid in the preparation of Investigational New Drug (IND) serial submissions and responding to queries from the Food and Drug Administration (FDA).

JobID: 20039303

The Regulatory Specialist will assist in the translation of regulatory requirements into practical application to ensure success in pre-approval drug development programs. Support regulatory agency interactions, communications, and preparation of submissions. Summary of Key Responsibilities: •Organizational Support •Regulatory Affairs Strategy and Management •Submissions •Regulatory Affairs Information and Intelligence. BS/BA in Life Sciences · 2+ years of experience in Pharma · Experience working with various government agencies.

Manage US projects and provide Regulatory guidance. ·Participate in Drug Development teams ·Counsel/advise on the US regulatory procedures ·Build/establish & manage effective FDA relationships ·Lead teams, plan meetings; provide strategic input for related materials ·Manage the preparation and review of regulatory applications, reports & correspondence ·Contribute to global cross-functional teams ·Define and manage project activities ·Maintain current knowledge of regulations ·Monitor competitor products and submissions ·Manage, promote and circulate regulatory info

  The University of North Carolina at Chapel Hill seeks a high-energy, service-oriented leader for the position of Director of the Office of Human Research Ethics. The OHRE is responsible for ethical and regulatory oversight of all human subject research at UNC. The OHRE oversees the planning, direction, and execution of the Institutional Review Boards and all related activities, with responsibility for approx. 4,500 active protocols. The OHRE Director reports to the Associate Vice Chancellor for Research and is responsible for the day-to-day management of professional and administrative staff. The OHRE Director will 1) assure compliance with federal, state, and institutional regulations, guidelines, and policies; 2) provide ongoing education, training, and mentoring for investigators, IRB members and staff, and university officials; and 3) oversee the OHRE office and its six IRBs, including operating budgets, and hiring, evaluation, promotion, and development of professional staff.

JobID: 01005046