Associate Director/ Director Regulatory Affairs CMC

2 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

    3 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

    3 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...

  • Clinical Director BCBA

    4 weeks ago

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

    Job Title: Clinical Director BCBAJob Summary: We are seeking a highly skilled Clinical Director BCBA to lead our behavioral analysis program. The ideal candidate will have a Master's degree, BCBA certification, and experience in behavioral analysis.Key Responsibilities:Develop and implement behavioral analysis programs for clientsLead a team of behavioral...

  • Deputy Director of Public Works/Traffic Engineer

    2 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

  • Catholic Music Director

    1 month ago

    Vacaville, California, United States Ladgov Corporation Full time

    Job OverviewLadgov Corporation seeks a skilled Catholic Music Director to lead our musical programs and provide accompaniment for liturgical services.Key ResponsibilitiesProvide professional-level accompaniment and cantoring for Masses and other Catholic services.Lead and execute choir rehearsals, form and direct volunteer children's and bell choirs, and...

  • 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:...

  • Financial Services Director

    4 weeks ago

    Vacaville, California, United States Wise Auto Group Full time

    At Wise Auto Group, we are seeking a highly skilled Financial Services Director to join our team in the East Bay area. The ideal candidate will have previous experience as a Finance and Insurance Manager in an automotive dealership and possess strong knowledge of financing options, lending practices, and insurance products.Key Responsibilities:Meet unit...

  • Clinical Director BCBA Position

    3 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

    3 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...

  • Activities Director

    4 weeks ago

    Vacaville, California, United States Pacifica Senior Living Vacaville Full time

    Pacifica Senior Living Vacaville is seeking a qualified Activities Director to establish and implement a stimulating leisure program for our residents.Key Responsibilities:Develop and lead a well-rounded activity program that addresses the spiritual, cultural, physical, intellectual, and social needs of residents.Key Skills:Assess resident needs and create...

  • Sales Director

    4 weeks ago

    Vacaville, California, United States Express Full time

    Key Responsibilities:As a Sales Leader at Express, you will be responsible for driving operations on the sales floor and in the stockroom. This includes assisting in training associates and delivering a great in-store shopping experience for customers. Additionally, you will assist in developing and motivating associates to maximize sales potential, execute...

  • Sales Director for New Home Communities

    4 weeks ago

    Vacaville, California, United States Blue Mountain Construction Services Full time

    Job SummaryThe Sales Director for New Home Communities at Blue Mountain Construction Services is responsible for overseeing and driving all sales operations and closings for new home communities. This position requires a strategic leader who can develop and execute sales strategies, ensure seamless coordination between key departments, and mentor the sales...

  • 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...