Manager, Global Regulatory Affairs, CMC

ph3Company Overview /h3 /brpAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com. As guided by Our Credo, Johnson Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson Johnson, we respect the diversity and dignity of our employees and recognize their merit. /p /brpAt Johnson Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at /p /brh3Job Information /h3 /brpJob Function: Discovery Pre-Clinical/Clinical Development /p /brpJob Sub Function: Regulatory Science /p /brpJob Category: Scientific/Technology /p /brpAll Job Posting Locations: Allschwil, Basel-Country, Switzerland, Schaffhausen, Switzerland /p /brpJob Description: About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at /p /brpPlease note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States: R- Belgium and Netherlands: R- Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. We are searching for the best talent for Principal Scientist (Manager), Global Regulatory Affairs, CMC. This is an onsite/hybrid role. /p /brh3Responsibilities /h3 /brul /brliParticipate as the Regulatory CMC Lead on CMC/Value Chain Teams and represent CMC Regulatory Affairs by providing regulatory expertise and input to team recommendations to facilitate successful product development globally. /li /brliActively participate on Global Regulatory Team(s) to develop global submission plans that comply with local regulatory requirements and commitments. /li /brliDevelop and execute global CMC regulatory strategy for one or more drug and/or delivery device, large molecule, vaccine, cell and gene therapy product(s). /li /brliLead the preparation of regulatory dossiers for submission to Health Authorities. /li /brliDevelop and gain agreement with project teams on the regulatory CMC strategy for Health Authority responses/interactions as needed. /li /brliMay lead/participate in selected initiatives within CMC RA / Global Regulatory Affairs (GRA). /li /brliDrive a culture of continuous improvement to ensure compliance with Johnson and Johnson standards, regulatory requirements and expectations. /li /brliCommunicates critical issues to Management. /li /brliMay represent CMC RA on Cross Functional Teams. /li /brliMay serve as a Single Point of Contact (SPOC)/Subject Matter Expert (SME) on internal and external teams to proactively influence policy and practice on specific areas of CMC regulatory expertise. /li /brliEnsure the CMC development and commercial product regulatory strategy meets global regulatory requirements over the lifecycle of the product and is in alignment with the strategies of GRA, the therapeutic area, commercial, regional functions and the Quality Target Product Profile (QTPP). /li /brliAssure connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs (Global Regulatory Leader). /li /brliEscalate issues to CMC RA Management that affect registration, regulatory compliance and continued lifecycle management of the product. /li /brliDevelop and update contingency plans for issues that may affect registration, regulatory compliance and the continued lifecycle management of the products in scope. /li /brliEffectively and tactfully communicate with health authorities; build positive relationships and maintain good rapport and credibility. /li /brliReview CMC regulatory dossiers for global submissions throughout the product lifecycle. /li /brliProvide accurate regulatory assessments of CMC changes to teams/projects and executes regulatory planning and implementation. /li /br /ul /brh3Qualifications / Requirements /h3 /brul /brliA BS/BA in biological, pharmaceutical, chemical or engineering sciences is required with a minimum of 8+ years of experience inclusive of post graduate education and/or pharmaceutical or health care industry experience or equivalent. /li /brliAn MS, Ph.D., or Pharm. D. degree is preferred. /li /brliSolid understanding of biology, chemistry and/or engineering relevant to pharmaceutical industry is required. /li /brliExperience in biologics, product development/LCM of the large molecules is required. /li /brliExperience developing regulatory strategies and an understanding of product development is preferred. /li /brliKnowledge of EU and FDA regulations is preferred. /li /brliDemonstrates model behavior that understands what the priorities are and encourages others to drive for results. /li /brliHigh-level verbal and written communication skills. /li /brliStrong attention to detail. /li /brliThe ability to potentially travel up to 10% travel, domestic and/or international. /li /br /ul /brh3Required Skills /h3 /brul /br /ul /brh3Preferred Skills /h3 /brul /brliBenchmarking /li /brliCoaching /li /brliConsulting /li /brliCorporate Governance /li /brliCritical Thinking /li /brliDrug Discovery Development /li /brliFact-Based Decision Making /li /brliHealthcare Trends /li /brliInterpersonal Influence /li /brliOrganizing /li /brliPublic Policies /li /brliRegulatory Compliance /li /brliRegulatory Development /li /brliScientific Research /li /brliStrategic Thinking /li /brliSubject Matter Experts (SME) Collaboration /li /brliTechnical Writing /li /br /ul /p #J-18808-Ljbffr