MANAGER
McNeil Consumer Healthare, a Division of McNeil-PPC, Inc, a member of the Johnson Johnson family of companies, is recruiting for a Manager, Regulatory Affairs Labeling for it's location in Ft. Washington, Pa.
McNeil Consumer Healthcare Division of McNEIL-PPC, Inc markets a broad range of over-the-counter products, including TYLENOL acetaminophen products, ZYRTEC and BENADRYL allergy medicines, IMODIUM A-D anti-diarrheal, MOTRIN IB, PediaCare upper respiratory medicines for infants and children, ROLAIDS antacid products, and SUDAFED nasal decongestants.
The duties of the Manager, Regulatory Affairs Labeling may include facilitating the preparation, compilation, approval management and distribution of Company Core Data Sheets, Drug Listing resolution of Import/Export Issues, issuing National Drug Code (NDC) numbers, preparation and maintenance of Drug Listings, and the review and approval of label components. The Manager is responsible for partnering with Global Regulatory Affairs to design and implement internal regulatory strategies to support new technology for McNeil Consumer Health Care (OTC) . This individual will interact with global regulatory colleagues located within and outside the US and produce cohesive development timeline to support those projects launching in multiple regions or globally. The Manager, Regulatory Affairs Labeling will interact with the FDA in support of Drug Listing submissions and interact with JJ cross-sector colleagues on new convergence opportunities that have consumer interest. This individual will interact with franchise regulatory, legal, medical, and safety colleagues in the creation of Company Core Data Sheets. This individual will provide a leadership role for assigned projects. The Manager, Regulatory Affairs Labeling will develop and maintain Standard Operating Procedures to support global regulatory strategies and develop best practice recommendations to improve consistency and quality of work within the global regulatory affairs group. This individual will act as the process expert for Drug Listings, Import/Export Resolution and Company Core Data Sheets and act as the subject matter expert for FDA regulations (proposed and existing) pertaining to Drug Listings. This individual will review and approve label components in Drug Facts format against FDA regulations.
All McNeil employees are required to cultivate an environment of quality compliance in their actions. This includes attending all required training, adhering to the processes procedures of their role and the company and displaying the highest level of integrity. Those who manage others are required to ensure their employees are trained appropriately, create maintain an environment that promotes employee involvement and doing things right the first time.
Qualifications
A minimum of a Bachelors degree and 5 or more years of related industry experience OR an advanced degree with 2 or more years of experience is required. Knowledge/familiarity with U.S. Drug Listing submissions is preferred. Experience working with the FDA and other regulatory agencies is preferred. Experience designing and implementing a global regulatory strategy is preferred. Experience in proofreading and or label review and approval preferred.
Excellent verbal and written communication skills are required. Strong presentation skills, including the ability to present and drive change to senior management are strongly preferred. Strong leadership and the ability to manage complexity are required. Strong interdependent partnering skills are required.