Current jobs related to Director of Regulatory Affairs-Labeling - Foster City - Milestone Technologies, Inc.

  • Senior Director, Regulatory Affairs

    1 week ago

    Redwood City, California, United States Corcept Therapeutics Full time

    Job SummaryCorcept Therapeutics is seeking a highly experienced Senior Director, Regulatory Affairs - Advertising, Promotion, and Labeling to support the commercialization of our late-stage programs. This role will involve operational and strategic responsibilities, including delineating regulatory strategies for commercial and corporate communications,...

  • Senior Director Regulatory Affairs

    2 weeks ago

    Redwood City, California, United States Corcept Therapeutics Full time

    Job Title: Senior Director Regulatory AffairsCorcept Therapeutics is a leading biopharmaceutical company dedicated to the research and development of cortisol modulators. We are seeking a highly experienced Senior Director Regulatory Affairs to join our team and support the commercialization of our late-stage programs.Key Responsibilities:Develop and...

  • Senior Director Regulatory Affairs

    2 weeks ago

    Redwood City, California, United States Corcept Therapeutics Full time

    Job Title: Senior Director Regulatory AffairsCorcept Therapeutics is a leading biopharmaceutical company dedicated to the research and development of cortisol modulators. We are seeking a highly experienced Senior Director Regulatory Affairs to support the commercialization of our late-stage programs.Key Responsibilities:Develop and implement regulatory...

  • Director, Biologics Regulatory Affairs

    2 weeks ago

    Foster City, California, United States Gilead Sciences Full time

    Job DescriptionGilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need.We are seeking a highly skilled Director, CMC Regulatory Affairs to lead our Biologics portfolio. As a key member of our team, you will be responsible for defining regulatory...

  • Regulatory Affairs Director

    2 weeks ago

    Jersey City, New Jersey, United States Mitsubishi Chemical Group Full time

    Job Title: Director, Regulatory Affairs (Early Development)Mitsubishi Tanabe Pharma America, Inc. is seeking a highly skilled Director, Regulatory Affairs (Early Development) to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic global regulatory guidance to cross-functional project teams...

  • Regulatory Affairs Director

    4 days ago

    Jersey City, New Jersey, United States Mitsubishi Chemical Group Full time

    Job Summary:Mitsubishi Tanabe Pharma America, Inc. is seeking a highly skilled Regulatory Affairs Director to join our team. As a key member of our regulatory affairs department, you will be responsible for providing strategic global regulatory guidance to cross-functional project teams responsible for product development.Key Responsibilities:Develop and...

  • Director, CMC Regulatory Affairs

    1 week ago

    Foster City, California, United States BioSpace, Inc. Full time

    Job SummaryGilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead's therapeutic areas...

  • Regulatory Affairs Director

    2 weeks ago

    Redwood City, California, United States Biomea Fusion, Inc. Full time

    Job Title: Associate Director, Regulatory AffairsBiomea Fusion, Inc. is seeking an experienced Associate Director, Regulatory Affairs to support the company's regulatory affairs strategies for IND/CTA/BLA/NDA filings and approvals.Key Responsibilities:Lead interactions and act as Subject Matter Expert on regulatory pharmaceutical and/or biotechnology...

  • Director of Regulatory Affairs

    2 weeks ago

    Texas City, Texas, United States Invenergy Full time

    Job Title: Director, Regulatory AffairsInvenergy is seeking a highly skilled Director, Regulatory Affairs to join our team. As a key member of our regulatory affairs team, you will be responsible for representing Invenergy before state economic and environmental regulators, transmission system operators, and regional trade associations in Texas.Key...

  • Director of Regulatory Affairs

    2 weeks ago

    Redwood City, California, United States Nuvig Therapeutics Inc. Full time

    Transformative Therapies for Autoimmune DiseasesNuvig Therapeutics is pioneering novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are designed to be active for a wide range of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment with existing therapies.Director, Regulatory...

  • Regulatory Affairs Specialist

    4 weeks ago

    Foster City, California, United States Integrated Resources, Inc ( IRI ) Full time

    Job Title: Senior Manager, CMC Regulatory Affairs, BiologicsJob Duration: 6 MonthsJob Location: Foster City, CAResponsibilities:Prepare Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals, and responses to agency questions for biologics products.Interact with departments outside of CMC Regulatory...

  • Regulatory Affairs Manager

    4 weeks ago

    Foster City, United States Integrated Resources, Inc ( IRI ) Full time

    Job Title- Senior Manager, CMC Regulatory Affairs, BiologicsJob Duration: 6 MonthsJob Location: Foster City,CA RESPONSIBILITIES MAY INCLUDE• Responsible for preparation of the Quality sections of INDs/IMPDs, new marketing authorization applications, post-approval variations, renewals and responses to agency questions, for a range of biologics products....

  • Regulatory Affairs Director

    4 weeks ago

    Redwood City, California, United States Work In Biotech Full time

    Transformative Therapies for Autoimmune DiseasesNuvig Therapeutics is pioneering novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are designed to be active for a wide range of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment with existing therapies.Director, Regulatory...

  • Regulatory Affairs Specialist

    4 weeks ago

    Foster City, California, United States ATR International Full time

    Regulatory Affairs Assistant - IIWe are seeking a highly skilled Regulatory Affairs Assistant - II to join our team at ATR International. This role is a great opportunity for someone who is passionate about advancing therapeutics against life-threatening diseases, while working with a collaborative team in Regulatory Affairs.Key Responsibilities:Perform data...

  • Regulatory Affairs Specialist

    4 weeks ago

    Foster City, California, United States Fladger Associates Full time

    Job Title: CMC Regulatory Affairs Data Entry SpecialistFladger Associates is seeking a highly skilled Regulatory Affairs Data Entry Specialist to join our team in Foster City, CA. As a key member of our Regulatory Affairs team, you will be responsible for performing data entry using our Company RIM System to support key CMC RA stakeholders.Key...

  • Regulatory Affairs Specialist

    2 weeks ago

    Foster City, California, United States Innova Solutions Full time

    Job DescriptionInnova Solutions is seeking a highly skilled Regulatory Affairs Assistant - II to join our team. As a key member of our Regulatory Affairs team, you will be responsible for performing data entry using our Client RIM System to support key CMC RA stakeholders.Key Responsibilities:Perform data entry using Client RIM System to enter relevant...

  • Senior Director, CMC Regulatory Affairs Biologics Project Lead

    4 weeks ago

    Foster City, California, United States BioSpace, Inc. Full time

    About the Role:The Senior Director, CMC Regulatory Affairs for Biologics is responsible for leading a matrix team of professionals, who work with a specific product in Gilead's global portfolio of biological products in CMC Regulatory Affairs. This position will provide leadership at a product level as a global lead that ensures right first time global...

  • Regulatory Affairs Director

    2 weeks ago

    Redwood City, California, United States Work In Biotech Full time

    Transformative Therapies for Autoimmune DiseasesNuvig Therapeutics is pioneering novel immune therapies to treat a broad spectrum of autoimmune diseases. Our treatments are designed to be active for a wide range of autoimmune diseases, without the inherent side effects and safety concerns of long-term treatment with existing therapies.Director, Regulatory...

  • Regulatory Affairs Specialist

    4 weeks ago

    Foster City, California, United States LeadStack Inc. Full time

    Job Title: CMC Regulatory Affairs Assistant II - Data EntryLeadStack Inc. is seeking a highly skilled and detail-oriented CMC Regulatory Affairs Assistant II - Data Entry to join our team. As a key member of our regulatory affairs team, you will be responsible for performing data entry using RIM System to enter relevant information to support key CMC RA...

  • Regulatory Affairs Assistant

    4 weeks ago

    Foster City, United States Fladger Associates Full time

    Description: Job Title: CMC Regulatory Affairs, Data Entry Contractor PositionContract Duration: 6 months (we would like to start with 6 months, with the potential to extend if the person is highly competent and a good resource for our team)Location: Remote- If the candidate is in the Foster City, CA area, we would prefer that they are onsite 2-3 days if...

Director of Regulatory Affairs-Labeling

3 months ago

Foster City, United States Milestone Technologies, Inc. Full time

Local Candidates Only, Please


Director, Global Regulatory Affairs Labeling


The Director, Regulatory Affairs Global Labeling will play a key role in providing regulatory expertise and guidance to internal stakeholders for successful development and implementation of global regulatory labeling strategy and documentation for marketed products. The Director will partner with all Regulatory Affairs functions, Medical Affairs, Legal, Clinical Development, Commercial and International distributors and will lead the Label Working Group. This role will report to the SVP, Global Regulatory Affairs.


JOB FUNCTIONS/RESPONSIBILITIES


Create and maintenance of labeling content for assigned programs of marketed product(s) and development products in US and international regions including: CCDS, prescribing information, medication guides, patient information/leaflet/IFU, package label artwork.


  • Leads the Label Working Group (LWG) and internal review and approval process of labeling documents.
  • Liaise with external partners or distributors in international markets, as applicable.
  • Conduct research on competitor and other relevant labeling precedents to support high quality, commercially viable labels to support company products.
  • Develop project timelines and manage labeling projects from initiation to completion.
  • Represent Regulatory Affairs at labeling meetings and provide strategic regulatory guidance, as appropriate.
  • Ensure labeling is compliant with local country regulations and guidance. This can be accomplished by managing and utilizing local resources (e.g., in-country or in-region labeling consulting services).
  • Author or collaborate with regulatory colleagues on regulatory submissions of labeling documents (package inserts, container labeling artwork).
  • Support International Regulatory Affairs colleagues when responding to local health authority queries regarding product labeling.
  • Act as primary contact for translation vendors in development of labeling documents in foreign languages.
  • Represent Global Regulatory Affairs on the Global Artwork Team; help develop, review, and approve global package artwork in close collaboration with Supply Chain, Quality Assurance, and International Regulatory Affairs colleagues.
  • Serve as an expert resource for regulatory labeling advice across departments.


Education/Experience:

  • Bachelor’s or advanced degree in a scientific discipline with a minimum of 12 years in Regulatory Affairs and a minimum of 8-10 years of regulatory labeling experience in the biopharmaceutical industry.
  • Experience with writing, developing, maintaining product labeling in the US and EU is required and around the globe is desirable including Asia-Pacific, LATAM, and Middle East.
  • Experience representing Regulatory Affairs Labeling on cross functional teams.


Knowledge, Skills and Abilities:

  • Excellent verbal, written, negotiation, influence and interpersonal communication skills are required.
  • Requires ability to work both independently and in a team environment, to set priorities to meet timelines, to motivate and influence others.
  • Must be self-directed.
  • Capable of critically reviewing complex technical/scientific documents.
  • Experience with global rules and regulations regarding labeling of medical products is highly desirable, as is experience with USFDA and international Health Authorities.
  • Experience with using Veeva Vault RIM and QualityDocs is desirable.
  • Resilient profile with the ability to deliver in an ambiguous environment.
  • Ability to engage multiple stakeholders to achieve the business objective, while building excellent working relationships.
  • Strong team player that is solution oriented.
  • Operationally excellent; ability to work simultaneously on multiple projects with tight timelines.


Work Environment:

  • This is a high growth, fast paced pharmaceutical company. The ability to be productive and successful in such a work environment is critical.
  • Some travel required. Responsibilities will require a flexible work schedule that may include periodically working outside of regular business hours, to meet business demands in a company with activities taking place around the globe.