Regulatory Affairs Associate (SCI)
Randstad Corporate Services in partnership with EMD Serono is actively seeking a Regulatory Affairs Associate to join the Global Regulatory Affairs department at their location in Rockland, MA. Randstad Corporate Services is known for our desire and ability to match people with companies and positions that will develop their potential. Our relationship with EMD Serono is no exception. EMD Serono is the North American biopharma brand of Merck KGaA, Darmstadt, Germany - a leading science and technology company focused exclusively on specialty care. For more than 40 years, the brand has integrated cutting-edge science, innovative products and industry-leading patient support and access programs. EMD Serono has deep expertise in neurology, fertility and endocrinology, as well as a robust pipeline of potential therapies in oncology, immuno-oncology and immunology as R&D focus areas.
Why Work With Us?
Pay: Competitive pay
Benefits: Health, dental, vision, short term disability, 401K after 90 days of service
Schedule: Monday thru Friday, 40 hours/week
Opportunities: Randstad provides temporary, temporary-to-hire and permanent positions each week to over 100,000 people through its network of more than 900 branches and on-site locations.
About the Job:
To support and manage the preparation of regulatory documentation for submission to FDA for assigned therapeutic areas/products and serve as a Regulatory Agency liaison for INDs, NDAs/BLAs, SNDA/SBLAs and maintenance activities including assessment and processing of manufacturing change controls for marketed products in Oncology and serve as a back-up for other activities (e.g., Neurology/Immunology, Reproductive Health, and Endocrinology)
-Lead regulatory US activities for approved products including leading, preparing and reviewing of regulatory documents such as FDA response documents, maintenance documents and labeling
-Represent US RA in global meeting
-Work with GRA colleagues to complete FDA requirements for approved products
-Lead and assess submission to the FDA
-Assist regulatory colleagues in improving internal process and them assessment of electronic document systems
-Serve as US team designee to Global Regulatory Subteams for assigned marketed products
-Collaborate and coordinate FDA interactions and submission activities with Marketed Product and Development Regulatory Leads in Global and Development Regulatory Groups
-Review and prepare regulatory documents for eCTD submission to FDA in compliance with requirements including Meeting Requests, Briefing Documents, CMC and Labeling supplements, General Correspondence, Annual Reports and Periodic Safety Reports, and other submissions.
-Technical assessment of submission content against commitments, regulations, and guidance documents
-Review of protocols, and additional regulatory documentation as required
-Interface with electronic submission operations group to ensure high quality and complete submissions
-Maintain appropriate documentation for FDA contacts and submissions according to SOPs
-Update and maintain Regulatory department tracking databases for planning, scheduling, submissions, action dates, and overall project coordination and management
-Agency liaison for NDA/BLA supplements, maintenance activities, and OPDP submissions, as required
Working hours: 8:00 AM - 1:00 PM
As an ideal candidate you will have-
--Excellent written and verbal communication skills
--Attention to detail, quality and follow-through
--Ability to collaboratively work in teams
--Project management and organization skills
--Ability to travel locally between Boston offices in Billerica and Rockland, MA
For consideration you must have???
-BS/MS Life Science degree or related discipline
-6+ years industry experience of which at least 4 years regulatory experience and/or RAC
-Working knowledge of FDA and international biologics/drug regulations
-Experience in project team membership
-Experience with regulatory agency interactions and preparation of documents for regulatory agency interactions
-Experience with regulatory maintenance activities for authorizations in a local affiliate or head office
Make sure your resume is up to date and apply! Thank you and we look forward to connecting with you!
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.