Sr. Regulatory Specialist

Piper Companies is currently looking for an experienced Sr. Regulatory Specialist (IND Submissions) in Philadelphia, Pennsylvania (PA) to work for an innovative and growing biologic oncology pharmaceutical company. The Sr. Regulatory Specialist will play an integral part in the regulatory IND submission process of new pharmaceutical products.

Responsibilities for the Sr. Regulatory Specialist (IND Submissions) include:

• Coordinate workload and timing for various regulatory submissions including interfacing with internal teams and stakeholders to build IND & CTA dossier content plans and routine regulatory submissions.

• Lead interactions with external publishing team to coordinate and assemble IND or CTA submissions including annual reports, safety reports, protocol amendments for new investigators, etc.

• Support authoring and manage document workflows for planned major submissions including health authority meeting packages, original INDs/CTAs, and protocol amendments:

• Lead interactions with external regulatory submissions vendor

• Collaborate with internal project team to facilitate IND/CTA document authoring and review workflows including SharePoint and Master Control responsibilities for regulatory affairs and CMC regulatory.

• Complete administrative sections of the IND/CTA

• Maintain regulatory systems and processes including the regulatory submissions and correspondences tracker, Regulatory SharePoint site, and file sharing tools used to interact with external vendors.

Qualifications for the Sr. Regulatory Specialist (IND Submissions) include:

• Hands on experience with the IND submission process

• Hands on experience with biologic oncology pharmaceutical preferred

• Regulatory affairs experience in one or more of the related regions ( US/FDA, Europe, Australia, China)

• Regulatory affairs experience in one or more of the related technologies (Cell and Gene Therapy, Oncology, Autoimmune Disease)

• B.S in Regulatory Affairs or related field

Compensation for the Sr. Regulatory Specialist (IND Submissions) include:

• Salary Range is dependent upon experience

• Comprehensive benefits package

Keywords

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