Job Description
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Senior Director, Global Labeling and Regulatory Affairs Intelligence
Job Location:  Auburn, Alabama, USA | Birmingham, Alabama, USA | Dothan, Alabama, USA | Huntsville, Alabama, USA | Madison, Alabama, USA | Mobile, Alabama, USA | Montgomery, Alabama, USA | Chandler, Arizona, USA | Flagstaff, Arizona, USA | Glendale, Arizona, USA | HavasuCity, Arizona, USA | Mesa, Arizona, USA | Phoenix, Arizona, USA | Scottsdale, Arizona, USA | Tucson, Arizona, USA | Yuma, Arizona, USA | FortSmith, Arkansas, USA | Jonesboro, Arkansas, USA | LittleRock, Arkansas, USA | Rodgers, Arkansas, USA | AlisoViejo, California, USA | Anaheim, California, USA | Bakersfield, California, USA | BeverlyHills, California, USA | Burbank, California, USA | Carlsbad, California, USA | Chico, California, USA | Cupertino, California, USA | Davis, California, USA | Encinitas, California, USA | Encino, California, USA | FosterCity, California, USA | Fresno, California, USA | Fullerton, California, USA | Hayward, California, USA | HuntingtonBeach, California, USA | Irvine, California, USA | LongBeach, California, USA | LosAngeles, California, USA | Modesto, California, USA | MountainView, California, USA | Napa, California, USA | Novato, California, USA | Oceanside, California, USA | Ontario, California, USA | PalmSprings, California, USA | PaloAlto, California, USA | Pasadena, California, USA | Petaluma, California, USA | Pleasanton, California, USA | RanchoCucamonga, California, USA | RedwoodCity, California, USA | Riverside, California, USA | Sacramento, California, USA | SacramentoSouth, California, USA | SanBernandino, California, USA | SanDiego, California, USA | SanDimas, California, USA | SanFrancisco, California, USA | SanJose, California, USA | SantaAna, California, USA | SantaBarbara, California, USA | SantaClarita, California, USA | SantaMonica, California, USA | SantaRosa, California, USA | SealBeach, California, USA | Sonoma, California, USA | Stockton, California, USA | Sunnyvale, California, USA | Temecula, California, USA | ThousandOaks, California, USA | Torrance, California, USA | Tustin, California, USA | Ventura, California, USA | WalnutCreek, California, USA | WestCovina, California, USA | Boulder, Colorado, USA | ColoradoSprings, Colorado, USA | Denver, Colorado, USA | DenverEast, Colorado, USA | FortCollins, Colorado, USA | GrandJunction, Colorado, USA | Lakewood, Colorado, USA | Bridgeport, Connecticut, USA | Danbury, Connecticut, USA | Fairfield, Connecticut, USA | Hartford, Connecticut, USA | Middlebury, Connecticut, USA | NewHaven, Connecticut, USA | NewHaven, Connecticut, USA | Southport, Connecticut, USA | Stamford, Connecticut, USA | Waterbury, Connecticut, USA | Washington, District of Columbia, USA | Dover, Delaware, USA | Wilmington, Delaware, USA | BocaRaton, Florida, USA | Bradenton, Florida, USA | Clearwater, Florida, USA | CoralSprings, Florida, USA | Destin, Florida, USA | FortLauderdale, Florida, USA | FortMyers, Florida, USA | Gainesville, Florida, USA | Jacksonville, Florida, USA | Jupiter, Florida, USA | Lakeland, Florida, USA | Largo, Florida, USA | Miami, Florida, USA | MiamiEast, Florida, USA | MiamiSouth, Florida, USA | Naples, Florida, USA | Ocala, Florida, USA | Orlando, Florida, USA | PalmBeach, Florida, USA | PanamaCity, Florida, USA | Pensacola, Florida, USA | PortSt.Lucie, Florida, USA | Sarasota, Florida, USA | St.Petersburg, Florida, USA | Tallahassee, Florida, USA | Tampa, Florida, USA | TampaSouth, Florida, USA | WestPalmBeach, Florida, USA | Albany, Georgia, USA | Alpharetta, Georgia, USA | Athens, Georgia, USA | Atlanta, Georgia, USA | Augusta, Georgia, USA | Columbus, Georgia, USA | Columbus, Georgia, USA | Kennesaw, Georgia, USA | Macon, Georgia, USA | Macon, Georgia, USA | Martinez, Georgia, USA | Norcross, Georgia, USA | Rome, Georgia, USA | Roswell, Georgia, USA | Savannah, Georgia, USA | UnionCity, Georgia, USA | Honolulu, Hawaii, USA | Boise, Idaho, USA | Pocatello, Idaho, USA | Aurora, Illinois, USA | Bloomington, Illinois, USA | Carbondale, Illinois, USA | Chicago, Illinois, USA | ChicagoSouth, Illinois, USA | Evanston, Illinois, USA | HighlandPark, Illinois, USA | Naperville, Illinois, USA | OrlandPark, Illinois, USA | Peoria, Illinois, USA | Rockford, Illinois, USA | Springfield, Illinois, USA | Waukeegan, Illinois, USA | Westchester, Illinois, USA | Chestertown, Indiana, USA | Evansville, Indiana, USA | FortWayne, Indiana, USA | Indianapolis, Indiana, USA | Merrillville, Indiana, USA | NewAlbany, Indiana, USA | SouthBend, Indiana, USA | TerreHaute, Indiana, USA | CedarRapids, Iowa, USA | DesMoines, Iowa, USA | Dubuque, Iowa, USA | IowaCity, Iowa, USA | QuadCities, Iowa, USA | SiouxCity, Iowa, USA | KansasCity, Kansas, USA | Lexington, Kansas, USA | OverlandPark, Kansas, USA | Topeka, Kansas, USA | Wichita, Kansas, USA | BowlingGreen, Kentucky, USA | Lexington, Kentucky, USA | Louisville, Kentucky, USA | Owensboro, Kentucky, USA | Somerset, Kentucky, USA | Alexandria, Louisiana, USA | BatonRouge, Louisiana, USA | Lafayette/LakeCharles, Louisiana, USA | NewOrleans, Louisiana, USA | Shreveport, Louisiana, USA | Portland, Maine, USA | Annapolis, Maryland, USA | Baltimore, Maryland, USA | Bethesda, Maryland, USA | Frederick, Maryland, USA | Gaithersburg, Maryland, USA | Hagerstown, Maryland, USA | Pikesville, Maryland, USA | Rockville, Maryland, USA | SilverSprings, Maryland, USA | Amherst, Massachusetts, USA | Boston, Massachusetts, USA | Foxboro, Massachusetts, USA | Framingham, Massachusetts, USA | Natick, Massachusetts, USA | NewBedford, Massachusetts, USA | Salem, Massachusetts, USA | SouthBoston, Massachusetts, USA | Springfield, Massachusetts, USA | Wilmington, Massachusetts, USA | Worcester, Massachusetts, USA | AnnArbor, Michigan, USA | Detroit, Michigan, USA | Flint, Michigan, USA | GrandRapids, Michigan, USA | NorthDetroit, Michigan, USA | Royal Oak, Michigan, USA | Saginaw, Michigan, USA | SouthernMichigan, Michigan, USA | Warren, Michigan, USA | Minneapolis, Minnesota, USA | SaintPaul, Minnesota, USA | Jackson, Mississippi, USA | CapeGirardeau, Missouri, USA | Fallon, Missouri, USA | KansasCity, Missouri, USA | Lee'sSummit, Missouri, USA | Springfield, Missouri, USA | St.Louis, Missouri, USA | St.LouisEast, Missouri, USA | St.LouisWest, Missouri, USA | Billings, Montana, USA | Lincoln, Nebraska, USA | Omaha, Nebraska, USA | LasVegas, Nevada, USA | Reno, Nevada, USA | Manchester, New Hampshire, USA | Nashua, New Hampshire, USA | Portsmouth, New Hampshire, USA | Annandale, New Jersey, USA | AtlanticCity, New Jersey, USA | BaskingRidge, New Jersey, USA | Bridgewater, New Jersey, USA | Camden, New Jersey, USA | Central, New Jersey, USA | CherryHill, New Jersey, USA | EastBrunswick, New Jersey, USA | EastHanover, New Jersey, USA | Edison, New Jersey, USA | Elizabeth, New Jersey, USA | FlorhamPark, New Jersey, USA | JerseyCity, New Jersey, USA | JerseyShore, New Jersey, USA | Madison, New Jersey, USA | Matawan, New Jersey, USA | Morristown, New Jersey, USA | MountHolly, New Jersey, USA | NewBrunswick, New Jersey, USA | Newark, New Jersey, USA | Paramus, New Jersey, USA | Parsippany, New Jersey, USA | Paterson, New Jersey, USA | Piscataway, New Jersey, USA | Plainsboro, New Jersey, USA | Princeton, New Jersey, USA | Raritan, New Jersey, USA | Ridgewood, New Jersey, USA | Rutherford, New Jersey, USA | SanBernardino, New Jersey, USA | SouthNewJersey, New Jersey, USA | TomsRiver, New Jersey, USA | Verona, New Jersey, USA | Wayne, New Jersey, USA | WestWindsor, New Jersey, USA | Woodbridge, New Jersey, USA | Albuquerque, New Mexico, USA | SanteFe, New Mexico, USA | Albany, New York, USA | Alden, New York, USA | Brentwood, New York, USA | Bronx, New York, USA | Brooklyn, New York, USA | Buffalo, New York, USA | GreatNeck, New York, USA | Hauppauge, New York, USA | Lancaster, New York, USA | LongIsland, New York, USA | Lynbrook, New York, USA | Manhattan, New York, USA | MidtownEast, New York, USA | NewYorkCity, New York, USA | Newburgh, New York, USA | Poughkeepsie, New York, USA | Queens, New York, USA | Rochester, New York, USA | StatenIsland, New York, USA | Syracuse, New York, USA | Utica, New York, USA | Webster, New York, USA | WhitePlains, New York, USA | Yonkers, New York, USA | Asheville, North Carolina, USA | Ashville, North Carolina, USA | Charlotte, North Carolina, USA | Columbia, North Carolina, USA | Durham, North Carolina, USA | Fayetteville, North Carolina, USA | Greensboro, North Carolina, USA | Greenville, North Carolina, USA | Hickory, North Carolina, USA | Huntersville, North Carolina, USA | Raleigh, North Carolina, USA | RTP, North Carolina, USA | Wilmington, North Carolina, USA | Winston, North Carolina, USA | Fargo, North Dakota, USA | Akron, Ohio, USA | Amherst, Ohio, USA | Cincinnati, Ohio, USA | Cleveland, Ohio, USA | Columbus, Ohio, USA | Dayton, Ohio, USA | Delaware, Ohio, USA | Dublin, Ohio, USA | NewAlbany, Ohio, USA | Portsmouth, Ohio, USA | Toledo, Ohio, USA | Youngstown, Ohio, USA | Zanesville, Ohio, USA | BrokenArrow, Oklahoma, USA | Norman, Oklahoma, USA | OklahomaCity, Oklahoma, USA | Tulsa, Oklahoma, USA | Eugene, Oregon, USA | Portland, Oregon, USA | Allentown, Pennsylvania, USA | Bethlehem, Pennsylvania, USA | Conshohocken, Pennsylvania, USA | Croydon, Pennsylvania, USA | Doylestown, Pennsylvania, USA | Easton, Pennsylvania, USA | Erie, Pennsylvania, USA | Harrisburg, Pennsylvania, USA | Hatfield, Pennsylvania, USA | Hazelton, Pennsylvania, USA | Johnstown, Pennsylvania, USA | Lancaster, Pennsylvania, USA | NewCastle, Pennsylvania, USA | Philadelphia, Pennsylvania, USA | PhiladelphiaSouth, Pennsylvania, USA | Pittsburg, Pennsylvania, USA | PlymouthMeeting, Pennsylvania, USA | Scranton, Pennsylvania, USA | WestPhiladelphia, Pennsylvania, USA | Williamsport, Pennsylvania, USA | York, Pennsylvania, USA | Providence, Rhode Island, USA | Charleston, South Carolina, USA | Columbia, South Carolina, USA | Greenville, South Carolina, USA | Spartanburg, South Carolina, USA | Bristol, Tennessee, USA | Chattanooga, Tennessee, USA | Jackson, Tennessee, USA | JohnsonCity, Tennessee, USA | Kingsport, Tennessee, USA | Knoxville, Tennessee, USA | Memphis, Tennessee, USA | Nashville, Tennessee, USA | TriCities, Tennessee, USA | Abilene, Texas, USA | Arlington, Texas, USA | Austin, Texas, USA | Brownsville, Texas, USA | Burleson, Texas, USA | CorpusChristi, Texas, USA | Dallas, Texas, USA | Denton, Texas, USA | ElPaso, Texas, USA | FortWorth, Texas, USA | Frisco, Texas, USA | Garland, Texas, USA | Harlingen, Texas, USA | HighlandVillage, Texas, USA | Houston, Texas, USA | Laredo, Texas, USA | Lubbock, Texas, USA | McAllen, Texas, USA | Paris, Texas, USA | Pearland, Texas, USA | Plano, Texas, USA | Rockwall, Texas, USA | SanAntonio, Texas, USA | Spring, Texas, USA | Texarkana, Texas, USA | Tyler, Texas, USA | Provo, Utah, USA | SaltLakeCity, Utah, USA | WestValleyCity, Utah, USA | Burlington, Vermont, USA | Alexandria, Virginia, USA | Arlington, Virginia, USA | Charlottesville, Virginia, USA | FallsChurch, Virginia, USA | Fredricksburg, Virginia, USA | Harrisonburg, Virginia, USA | Leesburg, Virginia, USA | Lynchburg, Virginia, USA | NewportNews, Virginia, USA | Norfolk, Virginia, USA | Reston, Virginia, USA | Richmond, Virginia, USA | Roanoke, Virginia, USA | VirginiaBeach, Virginia, USA | Washington, Virginia, USA | Williamsburg, Virginia, USA | Winchester, Virginia, USA | Bothell, Washington, USA | Redmond, Washington, USA | Renton, Washington, USA | Seattle, Washington, USA | Spokane, Washington, USA | Vancouver, Washington, USA | Charleston, West Virginia, USA | Morgantown, West Virginia, USA | Wheeling, West Virginia, USA | GreenBay, Wisconsin, USA | Madison, Wisconsin, USA | MenomoneeFalls, Wisconsin, USA | Milwaukee, Wisconsin, USA | Cheyenne, Wyoming, USA
Job Requisition ID:  13994

Join our global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes to our patients. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates it—where your skills and values drive our collective progress and impact.

 

The Global Labeling Senior Director provides regulatory expertise and guidance for labeling strategy, authors high quality labeling and artwork for drug/biological/device products, specific therapeutic/disease areas, and cross functional teams. Authoring by Senior Director of labeling and labeling components and is done by working with diverse cross-functional labeling sub teams collaborations. Will lead the Labeling Operations and Regulatory Intelligence groups for all activities, graphics process/systems, active regulatory intelligence monitoring and analyses to meet the Global Regulatory team’s needs.

 

Job Description

  • Actively authors and updates Target Product Profile (TPP), Company Core Data Sheet (CCDS), local labeling (USPI, SmPC, Canadian monographs, OTC monographs, device labeling, instructions for use) by assessing, extracting clinical, safety, CMC and other data and directly prepares appropriate wording for labeling
    • Note: Will not rely on SMEs to prepare the wording for original and updates for labeling
  • Lead the Labeling sub teams in the review, commenting and referencing labeling as cited above
  • Lead the Labeling Operations group for compliant label components (carton, container, graphics and SPL to deliver high-quality submission labeling and artwork, that meets timelines in collaboration with Commercial, Supply Chain, and GRA Product Leads
  • Lead all efforts for Regulatory Intelligence for routine monitoring and specialized assessments. Lead cross functional/regional Global Regulatory Affairs Regulatory Intelligence Team.
  • Evaluate and communicate cross regional risks associated with CCDS content updates and implementation strategies
  • Support global HA interaction strategy to discuss key labeling elements
  • Demonstrate high-level understanding of clinical, safety and CMC information/data and ability to extract for appropriate labeling content
  • Monitor, analyze and interpret new regulations and guidance, as well as monitor and determine impact on product labeling. Provides strategic advice on implementing new labeling regulations
  • Assess competitor labeling - understand precedents and opportunities for Health Authority (HA) discussions
  • Provide operational guidance and oversight to ensure all labeling documents are accurate, consistent, and compliant with all current regional regulatory regulation, guidance, templates, and requirements.
  • Manage and maintain labeling documents in document management systems and per labeling processes  
  • Partner with Global Regulatory Product Leads to ensure that all labeling is submission ready and available for publishing
  • During HA reviews, continuously assess dossier review comments for potential labeling impact, development of alternate proposals, and negotiation strategies
  • Lead, represent or contribute on product-specific Regulatory and Cross-Functional teams, as appropriate
  • Oversee team of approximately 10 individuals and outside contracting group

 

Qualifications Required

  • BSc or advanced scientific degree (MSc, PhD or PharmD) preferred.
  • 10+ years of relevant experience in pharmaceutical labeling/regulatory experience.
  • Thorough understanding of scientific principles, labeling and regulatory systems, relevant to drug development
  • Experience the actual writing CCDS, SmPC, Canadian Monographs, and USPI labeling and supporting documents for new products.
  • Solid understanding of pharmaceutical regulatory affairs, global labeling regulatory requirements and regulatory intelligence needs preferred
  • Strong understanding of medical concepts and terminology preferred
  • Strong written and oral communication skills, including presentation skills preferred
  • Solid ability to recognize and escalate issues preferred

 

The range of starting base pay for this role is 193K – 266K.  Actual starting pay will be based on a wide range of factors including, but not limited to, relevant skills, experience, qualifications, education and location. In addition to base pay, this position is eligible for participation in either (i) our annual bonus program or (ii) a sales incentive plan.

 

Benefits package includes a comprehensive Medical (includes Prescription Drug), Dental, Vision, , Flexible Spending Accounts, 401(k) with matching company contribution, discretionary time off, paid sick time, tuition reimbursement, parental leave, short-term and long-term disability, life insurance, accidental death & dismemberment insurance, paid holidays, employee referral bonuses and employee discounts. 

 

We are an Equal Opportunity Employer. EOE Disability/Veteran. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates collaboration.
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