Senior Manager/Associate Director, Regulatory Affairs CMC

Found in: Appcast Linkedin GBL C2 - 2 weeks ago

Vacaville, United States Polaris Pharmaceuticals Inc. Full time

Role Title: Senior Manager/Associate Director, Regulatory Affairs CMC

Department: Regulatory Affairs

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.

  • Senior Manager/Associate Director, Regulatory Affairs CMC

    1 week ago

    Vacaville, United States CareerBuilder Full time

    Role Title: Senior Manager/Associate Director, Regulatory Affairs CMC Department: Regulatory Affairs 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...

  • Senior Manager/Associate Director, Regulatory Affairs CMC

    1 week ago

    Vacaville, United States Polaris Group Full time

    Role Title: Senior Manager/Associate Director, Regulatory Affairs CMC Department: Regulatory Affairs 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...

  • Senior Manager/Associate Director, Regulatory Affairs CMC

    5 days ago

    Vacaville, United States Polaris Group Full time

    Role Title: Senior Manager/Associate Director, Regulatory Affairs CMC Department: Regulatory Affairs 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...

  • Senior Manager/Associate Director, Regulatory Affairs CMC

    1 week ago

    Vacaville, United States Polaris Pharmaceuticals Inc. Full time

    Role Title: Senior Manager/Associate Director, Regulatory Affairs CMCDepartment: Regulatory AffairsFLSA 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 to ensure regulatory...

  • Senior Validation Engineer

    Found in: Appcast US C2 - 2 weeks ago

    Vacaville, United States BEPC Inc. - Business Excellence Professional Consulting Full time

    BEPC has an open position for a Validation Engineer III in Vacaville, CA!!Contract W2 Period: 8-month contract with possibilities for extensions.Pay & Benefits: $67-$81/hr. + Medical, Dental, Vision and Life InsuranceThis is an onsite role; candidate should be local.Primarily responsible for the support and execution of laboratory equipment qualification...

  • Senior Validation Engineer

    Found in: Appcast US C2 - 2 weeks ago

    Vacaville, United States TalentBurst, an Inc 5000 company Full time

    Title: Validation Engineer III, Req#: ROCGJP00026009 Location: Vacaville, CA (100% onsite) Duration: 8 months Contract Job Description:Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations and the client’s corporate...

  • Senior Validation Engineer

    2 weeks ago

    Vacaville, United States BEPC Inc. - Business Excellence Professional Consulting Full time

    BEPC has an open position for a Validation Engineer III in Vacaville, CA!!Contract W2 Period: 8-month contract with possibilities for extensions.Pay & Benefits: $67-$81/hr. + Medical, Dental, Vision and Life InsuranceThis is an onsite role; candidate should be local.Primarily responsible for the support and execution of laboratory equipment qualification...

  • Senior Validation Engineer

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Vacaville, United States BEPC Inc. - Business Excellence Professional Consulting Full time

    BEPC has an open position for a Validation Engineer III in Vacaville, CA!!Contract W2 Period: 8-month contract with possibilities for extensions.Pay & Benefits: $67-$81/hr. + Medical, Dental, Vision and Life InsuranceThis is an onsite role; candidate should be local.Primarily responsible for the support and execution of laboratory equipment qualification...

  • Senior Validation Engineer

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Vacaville, United States TalentBurst, an Inc 5000 company Full time

    Title: Validation Engineer III, Req#: ROCGJP00026009 Location: Vacaville, CA (100% onsite) Duration: 8 months Contract Job Description:Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations and the client’s corporate...

  • Associate Dentist

    2 weeks ago

    Vacaville, United States Nut Tree Smiles Dentistry Full time

    Description: Overview: The Associate Dentist role is for any qualified individual, including recent dental school graduates. You will be given a unique opportunity to provide quality care for patients and to grow your career while receiving shoulder-to-shoulder coaching from an established Owner Dentist using the latest proven technology. You will...

  • Senior Building Inspector | Building Inspector

    Found in: Appcast US C2 - 1 week ago

    Vacaville, United States TRB and Associates, Inc. Full time

    TRB and Associates, Inc. is seeking an experienced and motivated Senior Building Inspector and Building Inspector with a minimum of five years of experience for a Senior Building Inspector and two years of experience for a Building Inspector in residential, commercial, and industrial structures. Experience as a building inspector for a city or county...

  • Senior Building Inspector | Building Inspector

    1 week ago

    Vacaville, United States TRB and Associates, Inc. Full time

    TRB and Associates, Inc. is seeking an experienced and motivated Senior Building Inspector and Building Inspector with a minimum of five years of experience for a Senior Building Inspector and two years of experience for a Building Inspector in residential, commercial, and industrial structures. Experience as a building inspector for a city or county...

  • Senior Building Inspector | Building Inspector

    Found in: Appcast Linkedin GBL C2 - 2 weeks ago

    Vacaville, United States TRB and Associates, Inc. Full time

    TRB and Associates, Inc. is seeking an experienced and motivated Senior Building Inspector and Building Inspector with a minimum of five years of experience for a Senior Building Inspector and two years of experience for a Building Inspector in residential, commercial, and industrial structures. Experience as a building inspector for a city or county...

  • Electric Emergency Management Specialist, Senior

    1 week ago

    Vacaville, United States Pacific Gas And Electric Company Full time

    Requisition ID# 156782 Job Category: Compliance / Risk / Quality Assurance Job Level: Individual Contributor Business Unit: Operations - Other Work Type: Hybrid Job Location: Vacaville; Alameda; Alta; American Canyon; Angels Camp; Antioch; Auberry; Auburn; Avenal; Avila Beach; Bakersfield; Balch Camp; Bear Valley; Belden; Bellota; Belmont; Benicia; Berkeley;...

  • Behavioral Health Associate II

    1 week ago

    Vacaville, United States Turning Point Community Programs Full time

    Job DescriptionJob DescriptionGENERAL PURPOSEUnder the general supervision of the Program Director or designee, this position is responsible for assisting members in meeting their expressed goals while living in the community. Additional support in areas of medication management, housing, vocation, counseling, and advocacy will be provided as...

  • Sales Associate

    Found in: Lensa US P 2 C2 - 2 weeks ago

    Vacaville, United States Strategis Companies, LLC Full time

    Location: **Vacaville Premium Outlet** **JOB TITLE: Sales Associate** **IMMEDIATE MANAGER: Store Manager** **DIRECT REPORTS: 0** **DIRECT REPORTS TITLES: N/A** **JOB CLASSIFICATION: Non - Exempt** **BUDGET RESPONSIBILITY: N/A** **THE PURPOSE** As a **Sales Associate**, you will maintain outstanding customer service as per company standards, achieve...

  • Quality and Compliance Specialist II/III

    Found in: Appcast US C2 - 5 days ago

    Vacaville, United States Polaris Pharmaceuticals Inc. Full time

    Role SummaryThe Quality & Compliance Specialist II/III is responsible for establishing and maintaining quality agreements with suppliers and laboratories, maintaining supplier qualification through audits and questionnaires, evaluating change notifications from suppliers, and reporting on the supplier/material qualification status. They may also be...

  • Quality and Compliance Specialist II/III

    Found in: Appcast Linkedin GBL C2 - 5 days ago

    Vacaville, United States Polaris Pharmaceuticals Inc. Full time

    Role SummaryThe Quality & Compliance Specialist II/III is responsible for establishing and maintaining quality agreements with suppliers and laboratories, maintaining supplier qualification through audits and questionnaires, evaluating change notifications from suppliers, and reporting on the supplier/material qualification status. They may also be...

  • Sales Associate

    Found in: Lensa US P 2 C2 - 5 days ago

    Vacaville, United States Spencer Gifts Full time

    Spencer's - JobID: J3Q1JR6HZ8LX1WYBYN0 [Retail Sales / Store Assocaite / Cashier] As a Sales Associate @ Spencer's, you'll: Maintain Guest Services; Efficiently operate POS, maintaining security of cash; Support the Store Management Team by generating sales, conducting housekeeping, merchandising, signing, pricing, POS operations and loss...

  • Sales Associate

    Found in: Lensa US P 2 C2 - 6 days ago

    Vacaville, United States Spencer Gifts Full time

    Spencer's - JobID: J3V75Y62D0675N27XQF [Retail Sales / Store Assocaite / Cashier] As a Sales Associate @ Spencer's, you'll: Maintain Guest Services; Efficiently operate POS, maintaining security of cash; Support the Store Management Team by generating sales, conducting housekeeping, merchandising, signing, pricing, POS operations and loss...