Regulatory affairs cmc manager Jobs | Glassdoor

Regulatory affairs cmc manager Jobs

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  • 4.8
    Sage Therapeutics – Cambridge, MA
    Est. Salary $113k-$183k
    17 days ago 17d
    business partners and regulatory agencies for all CMC related issues. Assess and communicate CMC regulatory requirements to ensure… thinker for a highly-visible role that is responsible for CMC regulatory activities, strategies and submissions supporting the development…
  • 3.2
    Shire Pharmaceuticals LLC – Cambridge, MA
    Est. Salary $82k-$118k
    20 days ago 20d
    Director of Regulatory Affairs direct and manage medical device Regulatory Affairs activities for developing global CMC medical device… 510k, Technical Files and or CMC sections of regulatory submissions and interactions with regulatory agencies. 25%: Develop global…
  • 4.3
    Ascent Services Group – San Diego, CA
    Today 10hr
    Manager Regulatory Affairs (CMC Biologics) San Diego, CA Permanent RESPONSIBILITIES Prepare and oversee submissions… Provide CMC regulatory support, guidance, and expertise to QA, QC, and Manufacturing teams; develop CMC regulatory strategies…
  • 4.0
    Softworld Inc. – Boston, MA
    12 days ago 12d
    Regulatory Affairs, CMC, Manager Bachelor's degree, Life/Health Sciences preferred. Minimum of 7 years in the Pharmaceutical… Able to implement regulatory strategy and coordinating regulatory CMC submissions Direct experience with CMC technical content…
  • 3.2
    Shire Pharmaceuticals LLC – Cambridge, MA
    20 days ago 20d
    development of contingency plans. Manage medical device Regulatory Affairs activities for developing global CMC medical device and IVD strategies… 510k, Technical Files and or CMC sections of regulatory submissions and interactions with regulatory agencies. 15%: Collaborate…
  • 3.6
    GlaxoSmithKline – Ware, MA
    Est. Salary $73k-$102k
    Today 9hr
    qualification. • Chemistry, Manufacturing and Controls (CMC) regulatory affairs or chemical and pharmaceutical development experience… highly motivated regulatory affairs professional responsible for Chemistry, Manufacturing and Controls (CMC) support for new medicines…
  • 4.3
    Ascent Services Group – North Waltham, MA
    18 days ago 18d
    Manager Regulatory Affairs CMC North Waltham, MA Permanent Responsibilities: Engage across the business and with external… discipline. Minimum of ten years CMC experience, including six years in Regulatory Affairs. Experience/background and training…
  • 3.4
    EMD Serono – Billerica, MA
    Est. Salary $117k-$160k
    3 days ago 3d
    level. Responsible for communicating regulatory strategy and defending Global Regulatory Affairs (GRA) positions to internal teams… work in teams Strong awareness of current trends in regulatory affairs Ability to think & plan strategically Good organizational…
  • 3.4
    Vertex Pharmaceuticals – Boston, MA
    Est. Salary $86k-$146k
    1 days ago 15hr
    Job Title Associate Director, Regulatory Affairs - CMC Req ID 8646BR Department Regulatory (NA) Posting Location Boston… in regulatory affairs CMC including managing post-approval changes for commercial products · Proficiency in regulatory (FDA…
  • 4.0
    Integrated Resources – Waltham, MA
    Est. Salary $62k-$99k
    13 days ago 13d
    Job Title: Manager, Regulatory Affairs CMC Location: Waltham, MA Duration: 12 Months (Contract To Hire) Job Description:… for preparation of CMC submissions for Biologics products. This position will also assist the Regulatory CMC team with special…
  • 5.0
    Cameron Craig Group – San Francisco, CA
    Est. Salary $184k-$249k
    Today 8hr
    level Regulatory Affairs professional with CMC expertise in the San Francisco Bay area, to drive US and Global Regulatory projects… SENIOR DIRECTOR, REGULATORY AFFAIRSCMC Our client, a progressive biopharmaceutical company, has a new opportunity for a…
  • 4.0
    Integrated Resources – United States
    Est. Salary $53k-$78k
    6 days ago 6d
    position of Associate, Regulatory Affairs-CMC will provide Chemistry, Manufacturing, and Controls (CMC) support for all current… of pharmaceutical OTC or Rx regulatory affairs CMC experience • Strong working knowledge of US CMC regulations and guidelines…
  • 4.0
    Johnson & Johnson – Titusville, NJ
    Est. Salary $110k-$157k
    9 days ago 9d
    -approval products. The Manager, Global CMC Regulatory Affairs will interact as necessary with the CMC and/or Value Stream Teams… Title: Manager, Global CMC Regulatory Affairs Janssen Research & Development, L.L.C., a Johnson & Johnson company, is recruiting…
  • 2.7
    Dendreon – Bridgewater, NJ
    Est. Salary $79k-$121k
    Today 4hr
    hope it will become. The Regulatory AffairsCMC Manager independently manages all regulatory CMC aspects of Valeant’s Pharmaceuticals… interactions on CMC issues. Qualifications: Knowledge of pharmaceutical industry regulatory affairs CMC discipline…
  • 3.7
    Alvogen – Pine Brook, NJ
    Est. Salary $65k-$95k
    15 days ago 15d
    pharmaceutical industry with 3 years of Regulatory Affairs experience · Exhibit strong knowledge of current CMC and ANDA related regulations…   The Senior Regulatory Affairs Associate position reports to the Associate Director of Regulatory Affairs.   RESPONSIBILITIES…
  • 3.1
    inVentiv Health Clinical – South San Francisco, CA
    Est. Salary $66k-$97k
    14 days ago 14d
    Title: CMC Manager, Regulatory Affairs Location: South San Francisco, CA Primary Function: This CMC Manager, Regulatory Affairs… launches. This CMC Manager, Regulatory Affairs will also cross-functionally collaborate with Quality and Regulatory groups as needed…
  • 3.5
    Merck – West Point, PA
    Est. Salary $80k-$136k
    6 days ago 6d
    its manifestations. Job: Regulatory Affairs - CMC Job Title:Assoc. Dir, Regulatory Affairs-CMC Primary Location: NA-US-… potential regulatory issues to GRACS CMC management, as needed - Demonstrate an understanding of regulatory affairs and apply…
  • 3.5
    Allergan – United States
    Est. Salary $79k-$135k
    14 days ago 14d
    This Director, Regulatory Affairs CMC will independently provide tactical and strategic leadership on complex CMC projects within… pharmaceutical or related experience and 8+ years of Regulatory Affairs / Regulatory CMC strategy perferred. PhD/MS 6+ years pharmaceutical…
  • The Computer Merchant, Ltd – Parsippany, NJ
    5 days ago 5d
    position of Associate, Regulatory Affairs-CMC will provide Chemistry, Manufacturing, and Controls (CMC) support for all current… of pharmaceutical OTC or Rx regulatory affairs CMC experience • Strong working knowledge of US CMC regulations and guidelines…
  • 3.4
    NexAge Technologies – Cambridge, MA
    Est. Salary $43k-$68k
    7 days ago 7d
    Represents Biopharmaceutical CMC Regulatory Affairs on regulatory networks and matrix teams, providing regulatory advice and guidance to… involvement in CMC-related activities and functions Preferred qualifications: • Experience in CMC regulatory affairs. • Experience…
  • 5.0
    JobJuncture – San Francisco, CA
    Est. Salary $94k-$162k
    19 days ago 19d
    level Regulatory Affairs professional with CMC expertise in the San Francisco Bay area, to drive US and Global Regulatory projects… SENIOR DIRECTOR, REGULATORY AFFAIRS CMC Our client, a progressive biopharmaceutical company, has a new opportunity for a Senior…
  • 3.8
    Spectraforce Technologies Inc – Northbrook, IL
    30+ days ago 30d+
    Bachelors degree in science 1-2 years in regulatory affairs CMC Good technical and regulatory knowledge of cGMP requirements and ICH… Bachelors degree in science 1-2 years in regulatory affairs CMC Good technical and regulatory knowledge of cGMP requirements and ICH…
  • 3.5
    Incyte Corporation – Wilmington, DE
    Est. Salary $74k-$114k
    2 days ago 2d
    Senior Manager, Regulatory Affairs CMC This position will primarily be responsible for managing regulatory CMC submissions… compliance is maintained. In alignment with RA-CMC leader, manage regulatory CMC strategy and submission aspects for both small…
  • 4.5
    TalentBurst – Allston, MA
    12 days ago 12d
    to the Associate Director, Global Regulatory CMC, this position will provide Regulatory CMC support for the Allston Biologics… drafting and finalizing CMC submission with Cerezyme RA-CMC product lead. Knowledge of Cerezyme regulatory history (including Consent…
  • 3.6
    GlaxoSmithKline – Rockville, MD
    Est. Salary $62k-$91k
    Today 9hr
    Coordinate and prepare regulatory submissions (such as clinical trial applications, IND submissions and amendments, CMC variations, support… towards the regulatory authorities • Provides/contributes to strategic input to assigned Global project teams for CMC and clinical…
  • 3.9
    Salix Pharmaceuticals – Bridgewater, NJ
    Est. Salary $116k-$190k
    10 days ago 10d
    Overview: The Regulatory AffairsCMC Director independently manages all regulatory CMC aspects of Valeant’s Pharmaceuticals… authority interactions on CMC issues. § Knowledge of pharmaceutical industry regulatory affairs CMC discipline throughout the…
  • 3.2
    Gilead Sciences, Inc. – Foster City, CA
    Est. Salary $109k-$162k
    13 days ago 13d
    meetings are chaired by a Regulatory Project Manager). Act as a "champion" of the Regional CMC Regulatory viewpoint. Work with… with RPTL to direct, manage and resolve CMC issues regarding the implementation of the global Regulatory CMC strategy. Work with…
  • 3.6
    Novartis – East Hanover, NJ
    Est. Salary $91k-$138k
    3 days ago 3d
    216354BR Posting Title Regulatory CMC Manager Division Global Drug Development Business Unit REG AFFAIRS GDD Country USA… activities 1.Author high-quality CMC regulatory documentation for HA submission, applying CMC global regulatory strategies, assuring technical…
  • 3.6
    GlaxoSmithKline – Rockville, MD
    Est. Salary $74k-$110k
    Today 9hr
    functions and the potential impact on regulatory affairs, including how regulatory affairs may facilitate in achieving the overall… provide strategic, scientific and regulatory affairs input, for all parts of regulatory affairs aspects of given project on technical…
  • 3.5
    Boehringer Ingelheim – United States
    Est. Salary $79k-$114k
    Today 9hr
    Business Operations, R&D, CMC, Quality Assurance, and other departments as appropriate • Provide regulatory assessments for proposed… in alignment with Business Operations, Industrial Operations, CMC, and R&D, responsible for the defense and maintenance of FDA-…
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