Regulatory Affairs Sr Associate/Specialist

Organisation Description
EMD Serono, Inc. is a leader in US biotechnology, focusing on reproductive health, metabolic endocrinology, and neurology. More than 500 people work in the world-class facilities in Rockland, MA, and approximately 250 work in the field.
Description

Purpose of the role:To perform regulatory affairs activities associated with development of investigational new drugs, registration of new products/indications, CMC changes and support of marketed products in assigned Therapeutic Areas.Prepares submissions and maintains applications / licenses for new drug / biological products, new devices, and new manufacturing facilities (INDs, NDAs, BLAs, sNDAs/sBLAs, PMAs, 510(k)s, Orphan, Fast Track designations, USAN, DMFs)Participates in the generation, elaboration and review of agreed elements of the core registration file to ensure compliance with local regulations and compatibility with US strategy and commercial business needs. Interacts with FDA Project Managers and FDA Reviewers, as appropriateProvides expert strategic regulatory advice for US registrations and functional support to: Regional Marketing & Therapeutic Business UnitsProduct launch, distribution, cGMPs / local inspections, phase IV studies, registries, technical complaints, labeling, promotion & advertising, and publication reviewClinical DevelopmentClinical trials (phase II and III) of investigational new productsWW ManufacturingNew and changes to manufacturing facilities and processes, inspections by U.S. health authorities (FDA)Project Based Organization MembershipParticipate in the project planning phase (early clinical development and major manufacturing initiatives) to develop a regulatory strategy and submission package which will be acceptable to the FDA Remains up-to-date on applicable laws, regulations and guidances such as:Food, Drug & Cosmetic ActPublic Health Services ActFood & Drug Administration Modernization ActPrescription Drug User Fee ActCode of Federal RegulationsFDA Guidances for IndustryInternational Conference on Harmonisation (ICH) GuidancesPending Congressional Legislation on Health and Governmental Policy Issues (e.g., drug importation, follow-on biologics, CMS, FDA Safety Office, disclosure of clinical trial data)Alert Director to issues and potential problems, delays and/or deficiencies making recommendations, as appropriateOtherProvides input into Guidances for Industry during their developmentProvides training to Field Sales Representatives, Speakers Bureau, Medical Science Liaisons, Nurse Educators, Call Centers Provides support to Legal department, as neededProvides direction to Medical Information and US Product Surveillance, as appropriateEnsures department databases are up-to-date
EDUCATION/LANGUAGESBA/BS (preferably with RAC, PharmD, or advanced degree)Fluent in EnglishPROFESSIONAL SKILLS & EXPERIENCE Minimum 3 years Regulatory Affairs or Pharmaceutical related experience. Basic understanding of FDA drug and biologic regulations and guidances (particularly clinical development and CM&C).Previous experience working with CDER and/or CBER; some DDMAC exposure desirable. PERSONAL SKILLS & COMPETENCIESResults oriented, sense of urgency, sound judgment and attention to details. Strong written and verbal communication skills. PC proficiency required. High level of professionalism. ESSENTIAL DUTIES Normal office dutiesTravel required