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Director of Requlatory Affairs

Pharmaceuticals Mfg
Chicago, Illinois, United States
$150-170K + Bonus
October 28, 2017

Director of Requlatory Affairs - $150-170K + Bonus – Pharmaceuticals Manufacturing - Responsible for management of the life cycle management and post approval teams including promotional material team. 70% - Regulatory Product Life Cycle Management and Post Approval Support–Provide regulatory leadership for Life Cycle Management and Post Approval Support maintaining and optimizing regulatory life cycle management and post approval. Integral team member with Project Management, Quality, Marketing, Business Development and partners to ensure marketed product compliance by in line with business objectives. Manage products from launch, in-licensing, acquisition through product life cycle. Review, assess, advise and lead regulatory life cycle management and post approval activities. Provide due diligence support to Business Development and Marketing in the review of potential in-licensing. Serve as product regulatory expert for Product Management, Project Management, Marketing, Sales, Project Management, Business Development, partners and technology teams as needed. Ensure the business needs for the assigned products are met by anticipating, identifying, prioritizing and mitigating regulatory risks while ensuring compliance with all regulatory requirements. Responsible for the oversight and management of life cycle management and post approval staff. 10% - Manage Regulatory Quality Systems– Manage and optimize quality systems within Regulatory Affairs including Executive Performance management metrics, standard operating procedures, documentation storage, database development and management for regulatory tracking to ensure FDA documents are stored in a cGMP complaint manner and are readily retrievable. 10% - FDA Liaison - Serve as the senior level regulatory interface with the FDA regarding life-cycle management, post approval, promotional advertising and other regulatory strategies.

10 or more years experience in research and development of new pharmaceutical products. 5 or more years in Regulatory Affairs. Pharmaceutical drug and/or device manufacturing experience; sterile injectable experience highly preferred; biologics and/or biosimiliars experience beneficial.

5 or more years experience supervising managers and/or staff. Experience supervising pharmaceutical drug development staff strongly preferred. Strong interpersonal communication skills required – verbal, written and presentation. Extensive experience successfully negotiating with, and interfacing directly with the FDA, partners and internal teams required. Experience leading successful FDA meetings to set preclinical, clinical, and CMC strategy. 505(b)(2) experience. Proven expertise in developing regulatory strategies, policies and procedures. Broad career progression within the pharmaceutical drug development and/or drug manufacturing industries strongly preferred with specific experience in labeling, quality, regulatory and manufacturing. Experience in developing, implementing, maintaining and optimizing departmental quality systems and databases.