Associate Director/ Director Regulatory Affairs CMC Job at Polaris Pharmaceuticals Inc., Vacaville, CA

dE9td3VNZGd0a3BRMTNYemp6V2dET3pvNUE9PQ==
  • Polaris Pharmaceuticals Inc.
  • Vacaville, CA

Job Description

Role Title: Associate Director/ Director Regulatory Affairs CMC

Location: Vacaville

Department: Regulatory Affairs

Reports to: CEO

FLSA Exempt

CORE VALUES

Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● Collaboration

ROLE SUMMARY

In this role you will provide CMC strategy input, authoring, and oversight of CMC-related regulatory items to ensure regulatory compliance of our products. You will collaborate with cross-functional teams and regulatory authorities to help drive CMC regulatory strategies, submissions, and approvals.

ROLE RESPONSIBILITIES

  • Develop and execute global CMC regulatory strategies in alignment with overall product development and registration plans.
  • Provide strategic guidance on CMC aspects of regulatory submissions including INDs, BLAs, and ex-US submissions.
  • Author and review of CMC-related regulatory documents for submissions including Module 2.3, Module 3, IMPD, CMC-related briefing documents, and other CMC-associated documents.
  • Provide oversight and coordination for the development of CMC portions of regulatory authority submissions.
  • Collaborate with internal teams and external partners to ensure adherence to global regulatory guidelines and requirements. Provide CMC regulatory guidance and support to internal teams including manufacturing/MSAT, Quality Assurance, and R&D.
  • Lead interactions with health authorities for CMC-related matters and prepare responses to inquiries.
  • Proactively identify and mitigate potential CMC regulatory risks or roadblocks, developing contingency plans as needed.
  • Participate in regulatory authority inspections and audits, as required.
  • Review and approve CMC regulatory documentation, ensuring compliance with regulatory requirements.
  • Provide CMC regulatory support for post-approval CMC-associated commitments as well as post-marketing CMC activities.
  • Drive continuous improvement initiatives related to regulatory processes, standards, and practices.

SKILLS & QUALIFICATIONS

  • Bachelor’s degree preferably in a scientific field. An advanced degree and regulatory affairs certification are desirable.
  • A minimum of 6-10 years in the biotechnology industry with 4-5 years in Regulatory Affairs CMC.
  • Background in biologics development is highly desirable.
  • Knowledge and experience with authoring and preparation of global regulatory submissions (IND, CTA, BLA, MAA), post-approval and post-marketing regulatory CMC activities.
  • Knowledge and experience with current Good Manufacturing Practices (cGMP), CMC regulations, and International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines.
  • Experience with CTD format and content.
  • Ability to work independently and in a group setting and to interact effectively with different functional areas.
  • Experience with US regulatory submissions; ex-US experience is desirable.
  • Detail-oriented with a focus on quality and compliance.
  • Strong project management skills, with the ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines.
  • Strong demonstrated experience with Microsoft Word, Project, and authoring templates.

Job Tags

Similar Jobs

United Gear & Assembly

Machine Operator weekend 2nd shift Job at United Gear & Assembly

 ...collaboration, to bring our customers high quality, cost effective solutions, delivered on time. Job Summary: Perform machine operations on Mills, Lathes, Grinders, Hobs and Broaches. ESSENTIAL DUTIES AND RESPONSIBILITIES Reads process sheets, blueprints, and... 

IP Casino Resort Spa

Security Officer - Part-Time Job at IP Casino Resort Spa

 ...Opportunity Employer and does not discriminate against any employee or applicant for employment because of race, color, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, and basis of disability or any other federal, state, or... 

Blue Signal Search

Safety Advisor, Field Operations Job at Blue Signal Search

 ...Safety Advisor, Field Operations Location: Challis, Idaho (primary project site) with nationwide travel Work Arrangement: Project based, on site rotation with paid travel Help build and sustain a proactive safety culture on a high visibility industrial... 

Unigen Corporation

Vice President of Global Supply Chain & Logistics Job at Unigen Corporation

 ...Job Title: Vice President of Global Supply Chain & Logistics Location: Newark, CA Department: Procurement Reports to: Vice President...  ...business. This includes procurement, logistics, inventory management, demand planning, supplier relations, and cost management... 

Scott Humphrey Corporation

Travel Construction Superintendent Job at Scott Humphrey Corporation

 ...We are seeking an experienced Construction Superintendent to oversee multiple Quick Service Restaurant (QSR) projects across the region. This is a travel-intensive role requiring hands-on leadership, project management, and strong subcontractor coordination to ensure...