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The position requires that the individual provide guidance and training; be responsible for submissions of reports and communications with the FDA; support for IND submissions; submission of IND reports; writing informed consent forms; amending protocols; creating and maintaining professional working relationships with investigators, sponsors, team members, and others. These responsibilities relate to the mission of the UNC/LCCC Protocol Office by maintaining the quality of research and by addressing patient safety and regulatory compliance which impact on research quality and safeguarding institutional integrity.

This Manager will be a deputy to the Head of Regulatory and Quality. Although the initial responsibilities will focus on labeling, the role will be diverse and dynamic. Seek candidate who enjoys contributing broadly. Company is developing several products that will be marketed in the US and abroad. Familiarity with US and ROW regulations and requirements will be important. As an emerging business, policies and practices are being developed and enhanced. Successful candidate will bring ingenuity, flexibility and drive. Specific responsibilities will include: *Assist in developing and implementing regulatory strategies for new and modified products * Provide regulatory expertise to colleagues and leadership. Help ensure regulatory compliance mindset within the company * Drive the coordination, development and execution of labeling projects (including obtaining labeling translations) for product portfolio 

Our client, a professional consulting services organization focused on medical device regulatory and quality compliance offers the opportunity to gain expansive portfolio experience found almost exclusively within a multi-client centered environment. Our client seeks experience generally evidenced by prior work history with a small medical device company or medical device consulting firm in both a regulatory affairs and quality assurance capacity.

A key member of the R&D leadership team, this position will lead and manage the company¿s global regulatory affairs organization. , This position is responsible for all regulatory activities, including but not limited to regulatory strategy, CMC regulatory, regulatory operations, labelling and promotional review, etc. Must lead by example and drive the regulatory strategy with the capability to both manage and execute the day-to day-operation of the Group This position will be responsible for both the gene therapy and small molecule aspects of regulatory affairs. Job ID: 150

RTI International is currently seeking a Senior Regulatory Affairs Scientist with a background and interest in clinical regulatory activities as it relates to biopharmaceutical development. The primary responsibility of this position will be to provide regulatory guidance, supplemental writing, and review of clinical reports and pertinent regulatory submission sections for drugs, biologics or diagnostics development projects. This individual will fulfill a key role with a focus on clinical affairs as a member of a team of scientists in RTI's Global Health Technologies Group working to develop new products to address critical unmet global health needs and opportunities. Minimum Qualifications: Ph.D. in a scientific or technical discipline with 6+ years' experience in biopharmaceutical drug development or clinical affairs; OR a Master's degree with 9+ years' relevant experience OR a Bachelors' degree with 12+ years of relevant experience.  Job ID 180m8

This newly created position following several acquisitions, reports to the Chief Executive Officer and works closely with the Chief Technology Officer. As a member of the Senior Leadership Team, you will work closely with the CEO and other members of the Senior Leadership Team to ensure successful attainment of all business goals and objectives.

RTI International is currently seeking a Regulatory Affairs Scientist with a background and interest in clinical regulatory activities as it relates to biopharmaceutical development. The primary responsibility of this position will be to provide regulatory guidance, supplemental writing, and review of clinical reports and pertinent regulatory submission sections for drugs, biologics or diagnostics development projects. This individual will fulfill a key role with a focus on clinical affairs as a member of a team of scientists in RTI's Global Health Technologies Group working to develop new products to address critical unmet global health needs and opportunities. JobID: 180fh

 A Biopharmaceutical company in Raleigh is looking for a Regulatory Affairs Consultant for a 6 month renewable contract. Ideal candidate will have the following: * New IND submissions * Maintenance of IND submissions * Strong scientific background * Meeting package preparation (preIND, end of phase 2) * Working in document management system * Submission management (tracking documents, managing timelines) * Protocol development, participation on clinical study team * Familiarity with NDA/BLA requirements (eg. CTD structure) * Experience with Health Canada submissions: CTA and CTA-amendment, CTSI.

Contact: Email: [email protected];  Phone: 678-654-4738

  The Regulatory Affairs Senior Manager develops and executes regulatory strategies for new products and life cycle management of existing products. Acts as primary contact for regulatory on cross functional product development and post-marketing teams and leads submission activities throughout product development and life cycle.

JobID: Regul01525

Assist Polaris Compliance clients with their compliance with GDPR regulations. Participate in planning and reviewing business proposals as requested; provide input regarding the feasibility of time lines, budgets, and resources available for projects. Provide input regarding the implementation of GDPR.