Regulatory Affairs Specialist, Market Support and Compliance

At The Merwin Group, we specialize in the placement of outstanding talent in the pharmaceutical / biopharmaceutical industry, combining a proven, targeted methodology and individual industry expertise to match the best candidates with the right companies. Client InformationOur client is a global biotechnology leader, focusing on autoimmune disorders, neurology, reproductive health, endocrinology and oncology.  Position SummaryProvide regulatory support and expertise to internal customers in order to ensure compliance with U.S. government requirements with regards to commercial activities, including primarily marketed product labeling and also advertising and promotional materials. Maintain company and relevant affiliates in compliance with government requirements for the import and distribution of products in the U.S. (e.g., import permits, licenses, registrations, listings). Essential Duties & Responsibilities· Develop, review, approve, track and release commercial labeling in accordance with local and corporate procedures and lead process improvement changes to increase efficiency and effectiveness of label review process· Develop systems and maintain highly organized and controlled records for historical current and ending labeling changes. Communicate labeling changes to stakeholders at time of implementation. Monitor for implementation by all parties using labeling including web sites, print promotion, and advertising.· Provide expertise and support to Supply Chain Department in terms of the management of Homeland Security import requirements for products (USDA, CUSTOMS, and FDA) in order to facilitate timely importation of shipments from abroad. Includes annual state wholesale distributor license and USDA permit renewals and assisting with import holds.· Prepare and submit timely drug and establishment registration listings for U.S. commercial products and U.S. and foreign manufacturing facilities for the company or its affiliates and follow-up with FDA regarding status or inquires. Routine surveillance of FDA databases for listing issues and resolution.· Assessment of support for marketing claims and data verification of Medical, Marketing, Managed Markets and Sales Training materials vs. source documents such as publications, clinical study reports, data on file. Perform reviews of proposed claims for compliance with FDA regulations 21CFR202.· Prepare metric reports of ongoing and completed activities by therapeutic area. Proactive follow-up with material proponents and Marketing Coordinators on material status. Alert supervisor of any delays or issues.· Participate in the development and implementation of Regulatory and Market Support Standard Operating procedures (SOPs).· Prepare and present training programs for speakers, sales and medical science liaisons, field nurses and call center staff. Provide regulatory guidance and support at live events, including filmings, with health care professionals and patients.· Special projects as assigned.· Some domestic and international travel is required and may include weekends. Required Skills, Experience and Keys to Success·  BS/MS in health related science·  Practical training and experience in regulatory policy is highly desirable·  3 - 5 years of expertise in a medical government-regulated field. Experience and/or training with the application of FDA and USDA regulations regarding drug and device labeling, importation, distribution, and promotion is highly desirable.·  Experience reading and critiquing medical/technical publications.·  Strong attention to detail and quality orientation·  Ability to provide accurate top-level analysis and recommendations for problem-solving·  Proficient PC skills (e.g., Word, Excel, Access, Acrobat, DataVision)·  Ability to multi-task and effectively manage multiple priorities·  Ability to communicate effectively to multiple levels in the organization·  Fluency in Spanish is desirable  MRINetwork is the largest and most successful search organization in the world. Each MRINetwork office is a single point of contact to over 1,100 offices in more than 37 countries, our candidates have access to the right jobs virtually anywhere in the world. LOCATION: Boston, MA JOB CATEGORY: Medical/Health TYPE: Full Time, Employee JOB REFCODE: 2285 COMPANY: The Merwin Group CONTACT NAME: Buddy Sullivan PHONE: 215-283-1800 X106 EMAIL: Apply by Email