Associate Director/ Director Regulatory Affairs CMC

3 months ago

vacaville, United States Polaris Pharmaceuticals Inc. Full time

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.

  • Associate Director/ Director Regulatory Affairs CMC

    3 months ago

    vacaville, United States Polaris Pharmaceuticals Inc. Full time

    Role Title: Associate Director/ Director Regulatory Affairs CMCLocation: VacavilleDepartment: Regulatory AffairsReports to: CEOFLSA ExemptCORE VALUES Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● CollaborationROLE SUMMARYIn this role you will provide CMC strategy input, authoring, and oversight of CMC-related regulatory items...

  • Associate Director/ Director Regulatory Affairs CMC

    4 months ago

    Vacaville, United States Polaris Pharmaceuticals Inc. Full time

    Role Title: Associate Director/ Director Regulatory Affairs CMCLocation: VacavilleDepartment: Regulatory AffairsReports to: CEOFLSA ExemptCORE VALUES Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● CollaborationROLE SUMMARYIn this role you will provide CMC strategy input, authoring, and oversight of CMC-related regulatory items...

  • Director of Information Technology

    4 weeks ago

    Vacaville, United States Pacific ExecSearch Full time

    Job Description Pacific Staffing is recruiting an experienced Director of Information Technology (IT) to manage the IT Department of an established regional community organization. The Director of IT will manage the development and implementation of departmental objectives and technical priorities for each department. This position will partner with the...

  • Director of Information Technology

    4 weeks ago

    Vacaville, United States Pacific ExecSearch Full time

    Job Description Pacific Staffing is recruiting an experienced Director of Information Technology (IT) to manage the IT Department of an established regional community organization. The Director of IT will manage the development and implementation of departmental objectives and technical priorities for each department. This position will partner with the...

  • Director, Associate Employment Law Counsel

    2 months ago

    Vacaville, United States Tandym Group Full time

    A pharmaceutical company is seeking an Associate Employment Counsel for their growing California division. This is a full-time Director-level position supporting the In-House Legal team.***This position will be primarily remote with occasional travel to Vacaville, CA.***Responsibilities:Provide day-to-day employment law advice and counseling on a broad range...

  • Director, Associate Employment Law Counsel

    1 month ago

    vacaville, United States Tandym Group Full time

    A pharmaceutical company is seeking an Associate Employment Counsel for their growing California division. This is a full-time Director-level position supporting the In-House Legal team.***This position will be primarily remote with occasional travel to Vacaville, CA.***Responsibilities:Provide day-to-day employment law advice and counseling on a broad range...

  • Director, Associate Employment Law Counsel

    4 weeks ago

    vacaville, United States Tandym Group Full time

    A pharmaceutical company is seeking an Associate Employment Counsel for their growing California division. This is a full-time Director-level position supporting the In-House Legal team.***This position will be primarily remote with occasional travel to Vacaville, CA.***Responsibilities:Provide day-to-day employment law advice and counseling on a broad range...

  • Deputy Director of Public Works/Traffic Engineer

    4 days ago

    Vacaville, United States City of Vacaville California Full time

    ABOUT OUR JOB The City of Vacaville is seeking a Deputy Director of Public Works/ Traffic Engineer who will be assigned to oversee and manage the Traffic Engineering Section of the Public Works, Engineering Services Division. The Deputy Director of Traffic Engineer, Director, Public Works, Deputy, Traffic, Engineer

  • Activities Director

    2 months ago

    Vacaville, United States Pacifica Senior Living Vacaville Full time

    Pacifica Senior Living is looking for an Activities Director to join our team! This position establishes a program of activities that is stimulating and that fosters a positive atmosphere through leisure activities that meet the spiritual, cultural, physical, intellectual, and social needs of residents both inside and outside the Community. Responsibilities:...

  • Clinical Director BCBA Position

    4 weeks ago

    Vacaville, California, United States Teach Acquire Thrive LLC Full time

    Job DescriptionTeach Acquire Thrive LLC is seeking a highly skilled Clinical Director BCBA to lead our team of professionals in providing exceptional behavioral services. The ideal candidate will possess a Master's degree, current BCBA certification, and a proven track record of success in creating, directing, and implementing behavior analysis programs.Key...

  • Facilities Maintenance Director

    4 weeks ago

    Vacaville, California, United States Polaris Pharmaceuticals Inc. Full time

    Job SummaryAt Polaris Pharmaceuticals Inc., we are seeking a highly skilled Facilities Maintenance Manager to join our team. This role will be responsible for managing the maintenance team members and contractors who support maintaining and repairing the cGMP processing equipment, process and building utilities, and the building infrastructure and...

  • Schools - COTA

    1 week ago

    Vacaville, United States ProCare Therapy Full time

    Job DescriptionJob DescriptionMinimum 1+ years occupational therapy experience required.Join a warm and close-knit school district! We have a full-time Certified Occupational Therapist Assistantopening to manage a K-12th gradecaseload. If you or someone you know is interested, check the details below and send me your resume to apply!Job Details:Onsite...

  • Temporary PT Sales Associate

    3 months ago

    Vacaville, United States Tapestry Full time

    since our launch in 1993 with a collection of six essential handbags, kate spade new york has always stood for optimistic femininity. today, our brand is a global life and style house with handbags, ready-to-wear, jewelry, footwear, gifts, home decor and more. polished ease, thoughtful details and a modern, sophisticated use of color-kate spade new york's...

  • Temporary PT Sales Associate

    3 months ago

    Vacaville, United States Tapestry Full time

    since our launch in 1993 with a collection of six essential handbags, kate spade new york has always stood for optimistic femininity. today, our brand is a global life and style house with handbags, ready-to-wear, jewelry, footwear, gifts, home decor and more. polished ease, thoughtful details and a modern, sophisticated use of color-kate spade new york's...

  • Accounting Manager

    4 weeks ago

    Vacaville, United States The Father's House Full time

    Benefits: Dental insurance Health insurance Paid time off TITLE: Accounting Manager DEPARTMENT: Finance CAMPUS: Vacaville/Central HOURS: Full-Time, 40 hours per week PURPOSE AND SUMMARY The Accounting Manager oversees and manages the accounting department’s day-to-day operations. This role is responsible for ensuring the accuracy and completeness of...

  • Clinical Director BCBA

    2 months ago

    Vacaville, United States Teach Acquire Thrive LLC Full time

    Job DescriptionJob DescriptionPosition Summary: This position will be responsible for creating, directing, monitoring, analyzing, and implementing behavior analysis programs for assigned clients. The incumbent works with individuals and groups to promote optimum treatment outcomes through the acquisition of socially significant adaptive behaviors and...

  • Board Position Care Liaison

    4 weeks ago

    Vacaville, United States CURO Health Services Full time

    We are looking for a Home Care Account Manager who enjoys building relationships and selling services in the healthcare industry. This position reports to the Area Director of Sales or VP of Regional Operations and is responsible for maintaining rela Liaison, Account Executive, Relationship Manager, Healthcare, Territory Sales, Client Relations, Business...

  • Facilities Maintenance Manager

    5 months ago

    Vacaville, United States Polaris Pharmaceuticals Inc. Full time

    Role Title: Facilities Maintenance ManagerDepartment: FacilitiesSupervisor: Director of FacilitiesFLSA: ExemptCORE VALUES Respect ● Passion ● Teamwork ● Integrity ● Honesty ● Commitment ● CollaborationROLE SUMMARYThe Facilities Maintenance Manager role will be responsible for managing the Polaris maintenance team members and contractors that...

  • Clinical Laboratory Scientist II- Vaca Valley Per Diem

    3 months ago

    Vacaville, United States NorthBay Health Full time

    At NorthBay Health the Clinical Laboratory Scientist II is a staff level position reporting directly to the Supervisor, Laboratory Director and the Medical Director assigned to perform, interpret, and report accurate and timely laboratory testing in the sections of the laboratory assigned according to standard operating procedures and policies and in...

  • Senior Physical Therapist, 36 Hour, Neuro

    3 months ago

    Vacaville, United States Kaiser Permanente Full time

    Job Summary: Provides independent physical therapy management of patients under the direction of the Rehabilitation Services Director or designee. Provides physical therapy services in specialized patient care clinics, and assists in the development, implementation and review of departmental patient care programs. Essential Responsibilities: Evaluates...