Regulatory Affairs Senior / Consultant - Regulatory Lead (Home Based East Coast US or Canada)

Are you a seasoned regulatory expert with a passion for guiding innovative pharmaceutical products through the complex landscape of clinical development? Parexel is seeking a dynamic and strategic Senior / Consultant - Regulatory Lead to join our team. In this pivotal role, you will lead regulatory submissions, ensure compliance with global regulations, and collaborate with multidisciplinary teams to bring groundbreaking therapies to market. If you thrive in a fast-paced environment and are eager to make a significant impact on global health, we want to hear from you!

As a Regulatory Affairs Senior / Consultant - Regulatory Lead, you will be responsible for:

Strategic and Operational Leadership:

• Focus on clinical regulatory filings

• Provide strategic and operational leadership on project teams

• Support ongoing clinical development activities

• Lead IND/CTA and BLA submissions for products in development and marketed products

Regulatory Knowledge and Application:

• Integrate and apply knowledge of global regulations, with emphasis on US FDA regulations

• Ensure compliance with pharmaceutical drug development regulations across quality, preclinical, and clinical programs

• Monitor and interpret newly published FDA guidelines and international guidance documents

• Provide training on applicable requirements for scientific staff as needed

Regulatory Strategy Development:

• Develop regulatory strategies for assigned programs in collaboration with senior management

• Analyze guidance and assess precedent information for similar indications

• Obtain approval for activities supporting development and marketing objectives within specified timelines

Health Authority Communication:

• Communicate with FDA and other health authorities for assigned programs

• Manage regulatory activities associated with drug development programs

Submission Management:

• Plan, prepare, and submit Investigational New Drug Applications (INDs) and Biologic Licensing Applications (BLAs)

• Manage IND amendments, annual reports, and other regulatory documents and correspondence

• Ensure completeness and accuracy of all regulatory submissions

Multidisciplinary Team Collaboration:

• Participate in and provide regulatory guidance to multidisciplinary project teams

• Communicate regulatory goals and requirements to team members

• Guide teams on content, format, style, and architecture of regulatory applications

Document Preparation and Review:

• Edit or manage the editing of scientific sections of regulatory applications

• Assist with writing, reviewing, and preparing regulatory documents

• Perform critical analyses of clinical, preclinical, and manufacturing data

• Develop independent interpretations and conclusions

• Review clinical protocols and study reports to identify deficiencies or missing information

BLA-Specific Responsibilities:

• Provide guidance on Biologics Licensing Application (BLA) preparation

• Assist with scientific writing and review of BLAs

• Evaluate BLA conformance with regulatory requirements

Qualifications:

• Bachelors or Advanced degree in a scientific discipline (Ph.D. or equivalent preferred)

• Minimum of 5+ years of experience in regulatory affairs in a similar capacity within the pharmaceutical or biotechnology industry

• Extensive knowledge of global pharmaceutical regulations, particularly US FDA regulations. Depth of previous experience will determine Consultant or Senior Consultant level

• Strong understanding of drug development processes and regulatory requirements with an emphasis on clinical module requirements

• Excellent analytical, writing, and communication skills

• Previous experience authoring Orphan Drug Designation Meeting packages

• Ability to work effectively in multidisciplinary teams

• Experience in managing regulatory submissions, preferably INDs and BLAs

• Previous experience successfully leading cross functional teams in a deadline focused regulatory environment

• Previous Biologics experience

Due to the nature of the role and client and team interaction, candidates located in the EST are highly preferred.

10-15% travel may be required

This position requires a detail-oriented individual with strong leadership skills, capable of managing complex regulatory processes and ensuring compliance with global pharmaceutical regulations.

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