Sr. Manager, Regulatory Affairs
BioPhase Solutions - San Diego, CA

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BioPhase Solutions specializes in recruiting top talented professionals for San Diego's Scientific community. We are currently looking for a Sr. Manager, Regulatory Affairs to work for a leading San Diego biotechnology company.

Sr. Manager, Regulatory Affairs

Working in a team environment, the Regulatory Affairs Senior Manager will be responsible for executing regulatory strategy as well as hands-on management of all technical and operational aspects related to the regulatory lifecycle (e.g., from preclinical candidate designation through registration) of assigned products.

Strategic Planning

Represent the Regulatory Affairs department on multidisciplinary product development teams

Participate in the development and implementation of regulatory strategy for one or more programs

Research regulatory precedent related to product class and therapeutic area(s) and assess implications for product development/registration

Contribute to product development plans (PDP) and target product profile (TPP)

Regulatory Operations

Manage all operational aspects of regulatory submissions, including maintaining timelines; organizing submission content; and coordinating the internal/external authoring and review of components of original investigational drug applications, amendments, and IND safety and annual reports

Interface with external Regulatory Operations group in the compilation of regulatory submissions in electronic common technical document (eCTD) format

Prepare and/or implement standard regulatory submission content templates

Prepare briefing documents for milestone regulatory meetings

Compliance

Review and communicate current and emerging regulatory requirements for quality, preclinical, and clinical programs to ensure compliance of all development activities with applicable US and international regulations and guidelines

Author and review standard operating procedures (SOPs); ensure SOPs are in compliance with current regulatory requirements

Monitor company progress toward fulfillment of regulatory commitments

Requirements:
Bachelor degree in a life sciences discipline; advanced degree preferred

Minimum of 5 years experience in pharmaceutical Regulatory Affairs with focus in development of drugs/biologics

Hands-on experience in preparation, submission and lifecycle management of investigational/marketing applications in eCTD format

Experience directly interfacing with regulatory authorities

In depth knowledge of GXP/ICH guidelines and regulations

Experience in CNS-related therapeutic area a plus

Strong written and verbal communication, analytical and interpersonal skills

Proven ability to interact effectively across multiple functional groups and projects

BioPhase Solutions - 4 months ago - save job - block
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