Manager, Regulatory Affairs - Berkeley Heights, NJ

This is a six-month contract position for a Regulatory Affairs Specialist to provide regulatory advice and risk assessment to Commercial Teams. The role involves providing innovative solutions and advice on promotional materials and ensure full regulatory compliance. · Provides r ...

The Regulatory Affairs Associate manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. · With input from the submission teams this individual establishes and maintains submission content planners and associated timelines ...

The Associate manages submission projects involving multiple cross-functional regulatory submission teams. · Responsibilities · Acts as RA Submissions support providing guidance and communication of established submission processes. · ...

This position reports to the Executive Director, Lymphoma Disease Lead, and is a key member of the US Medical Lymphoma Team. The primary responsibility of the Associate Director is to work across the Medical matrix teams, driving strategy and planning of external thought leader e ...

+Under general direction, responsible for successfully filing original Abbreviated New Drug Application submissions and for managing post approval changes requiring regulatory submissions. · ...

The Associate, Regulatory Affairs Submission Management manages low to medium impact submission projects involving multiple cross-functional regulatory submission teams. · Manages low to medium impact (with respect to internal visibility, risk, complexity and criticality) submiss ...

Under general direction, responsible for successfully filing original Abbreviated New Drug Application submissions and for managing post approval changes requiring regulatory submissions. · ...

Under general direction, responsible for successfully filing original New Drug Application submissions and for managing post approval changes requiring regulatory submissions. · ...

Responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations and guidances. · ...

The IME Medical Education Manager will work under the direction of an IME Director. · Help ensure compliance and quality of supported medical education programs within the assigned therapeutic area via tracking of outcomes and educational effectiveness: · ...

Under general direction responsible for successfully filing original Abbreviated New Drug Application submissions and for managing post approval changes requiring regulatory submissions. Can be primary contact with regulatory authorities for assigned projects and products. · ...

The CMC Regulatory Affairs Specialist will be responsible for developing and implementing regulatory strategies for assigned pharmaceutical products in accordance with global regulations and guidances. · ...

This position reports to the Myeloid Medical Promotional Review lead and is a key member of the US Medical Affairs Myeloid Team.The primary responsibility is to support the strategic review of promotional materials from a medical lens for Client products. · Advanced Degree · , Cl ...

+Snr. Nonclinical Safety Writer responsible for partnering with toxicologists on drug development programs to support regulatory document preparation and review. · +Partner with Toxicologists on drug development programs to support regulatory document preparation and review. · Pr ...

This role plays a key role within the Regulatory Affairs organization and is responsible for ensuring promotional and non-promotional materials meet the regulatory requirements with US health agency laws and regulations. · Participate in review meetings providing regulatory input ...

We are hiring Regulatory Affairs Associate I. · Please let me know if you are interested or anyone who might be interested. · Client: Major Cosmetics Client · Position: Regulatory Affairs Associate I · Duration: 11+ months · Location: Clark, · NJ 07066 ...

+ Job summary + · The contractor will provide Regulatory Affairs Operations support focused on BLA compilation and quality control (QC) activities. · + ResponsibilitiesSupport assembly and maintenance of BLA submission modules (including CMC, nonclinical, and clinical sections) · ...

The contractor will provide Regulatory Affairs Operations support focused on BLA compilation and quality control activities. · Bachelor's degree in a life science pharmacy regulatory science or related discipline. · 2+ years' experience in regulatory submissions compilation or do ...

The position will require a basic understanding and application of US Food and Drug Administration labeling regulations to ensure the accuracy and regulatory compliance of ingredient statements, nutrition facts, allergen declarations, and claims. · ...

We are hiring Regulatory Affairs Associate I. · Please let me know if you are interested or anyone who might be interested. Review formulas for compliance with local regulations in US and Canada. · Reviewing artwork for US and Canada Compliance. · Notifying products in US and Can ...