Manager of Regulatory Affairs

Manager of Regulatory Affairs Our client, located in the Boston, MA area, is a specialty pharmaceutical company, focusing on the discovery, development and marketing of pharmaceuticals for multiple indications. Job Responsibilities:  Develop regulatory strategies, file applications to domestic and international regulatory agencies Advise the company on regulatory issues concerning the company’s products and operations Ensure that regulatory submissions (IND, NDA, CTA) are high quality and filed in a timely manner to meet business objectives Develop Standard Operating Procedures and other departmental procedures according to current regulations and/or guidelines. Develop standard operating procedures and standard business practices to assure consistent approaches to producing regulatory deliverables Partner with internal departments to assure that their respective development plans align with regulatory requirements. Evaluate advertising and promotional material for compliance with approved labeling and applicable regulatory requirements Represent Regulatory Affairs on project development teams Job Requirements:  B.S. degree in a scientific discipline. Advanced degree preferred Minimum 5-7 years regulatory affairs experience in the pharmaceutical industry Substantial FDA interface experience Proven track record in filings of INDs, NDAs, CTAs, MAAs preferably in CTD or e-CTD format DDMAC experience is a plus Solid organizational and communication skills, strong knowledge of the regulations, excellent interpersonal negotiation skills with the proven ability to positively influence othersLocations:Cambridge, MA & Boston, MA Compensation: $92,000.00Compensation commensurate with experience. For confidential consideration, please forward your resume in a Word document to bthornton@kleinhersh.com . Visit www.kleinhersh.com to view other job opportunities available through our company. 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: Cambridge, MA JOB CATEGORY: Legal TYPE: Full Time, Employee JOB REFCODE: bt-regaff-m COMPANY: MRINetwork EMAIL: Apply by Email