For The Candidates

(5) Openings- Ra Manger- Ra Sr. Manager - RA Director CMC - Regulatory affairs- Biologics NJ Type: Full-Time Category: Regulatory Affairs Job ID: 740 Opportunity Description: ( 908 ) Area code                                     Northern , NJ   Regulatory Director of CMC   Job Summary: GENERAL SUMMARY Advanced knowledge of regulations, guidance documents and corporate/industry standards and an ability to evaluate same for impact on strategic plans and tactical operations. Good scientific/technical knowledge, provides committed, value-added effort in support of development projects. Must be detail-oriented with good oral and written communications skills; able to supervise the preparation of accurate, clear and concise regulatory documents. Excellent time management skills essential; must be able to multi-task and develop timelines for deliverables. Represents CMC Regulatory Affairs internally and facilitates communication with external parties including health authorities. Possesses advanced leadership skills, mentors more junior level regulatory professionals. ESSENTIAL DUTIES AND RESPONSIBILITIES: 1.Will have a comprehensive understanding of regulatory requirements including FDA, EMEA, ICH guidelines and relevant government regulations (21 CFR, EU Directive) as they apply to the registration, development, and approval of investigational products as well as post approval changes to marketed products, with an emphasis on Chemistry, Manufacturing, and Controls (CMC) and the regulation of biologics. 2.Coordinates the preparation of CMC submissions through editing and approval of final draft documents, including review for accuracy, soundness, and regulatory appropriateness. 3.Responsible for IND maintenance including amendments and annual reports and timely regulatory approval and registration of clinical supplies, including regulatory process compliance. 4.As the regulatory representative to the cross-functional Core Team, the Director provides regulatory guidance to ensure development activities are compliant with relevant guidelines and government regulations. 5.Proposes strategy for approval of investigational products and post approval changes for marketed product, communicates departmental consensus strategy to Core Team and/or Manufacturing. 6.Reviews for regulatory compliance and approves validation protocols and reports, batch records, analytical methods, specifications and finished product labels, etc. 7.Assesses regulatory impact and approves change controls/requests for development and marketed products. 8.May liaise with regulatory agencies and facilitate regulatory communications. 9.The Director may manage the activities of more junior level regulatory professionals ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE: 1.Must have 9 - 14 years of Pharmaceutical Industry experience including a minimum of 5 years of regulatory or related experience. 2.Comprehensive knowledge of the drug development process and government regulations/guidelines, including US and international product registration. 3.Excellent oral and written communication skills including the preparation of moderately complex submissions. 4.Experience supervising and mentoring junior staff members, including effective work delegation. 5.BA/BS degree or equivalent experience.   If you are interested in the company name and exact location for this opportunity, please enter your email address below.

Get In Touch With Us

Client Testimonials

"My confidential career search was handled with respect and they listened to what I wanted. I moved from New Jersey to Colorado with help from InVision Inc."

"I have never seen this quality of talent assembled for a Regulatory Vice President opening. Regulatory staffing is very unique. InVision produced great results in a short amount of time."

"I called InVision on a Tuesday morning with a very unique regulatory opening and they presented (4) qualified candidates in 3 days... We hired the second person they submitted. Results! Thank You"

"The staff at InVision prepared me for a great interview and guided me along the interview process step by step. Unique niche recruiters have come and gone InVision has been around for years and having RA/QA knowledge really helps."

"Your friend Paula should contact the world's greatest RA and QA recruiting company, InVision I can serve as a reference if needed."

"I sent InVision my regulatory resume looking to relocate to California and they presented (2) director level openings right away and they followed up with me. Feedback from my resume really helped."