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Manager, Regulatory Affairs

Schaumburg, IL 60195

Posted: 09/17/2018 Job Category: Clinical: Regulatory Job Number: 2079

Serves as the primary regulatory interface with Partners and internal teams.  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.   Develops and oversees the regulatory strategy, preparation and review of FDA Submissions including NDA’ s, ANDA’ s, Amendments and Labeling changes. Ability to make decisions that may have implications on the strategy, management and operations of an area within a department. 

Success for this role would be measured primarily by the following:
  • Provide in-depth and timely Regulatory strategy/input for all new development projects and in-licensing projects
  • Accurate interpretation and implementation of the regulatory requirements leading to the highest quality regulatory submissions.
  • Timely submission of new regulatory applications and amendments.
  • Preparation and submitting high quality and accurate new original applications and amendments to secure timely application approvals. 
  • Reductions in time to market as a result of continuous operational improvement initiatives
  • Ensuring the quickest possible approval and launch of new products.
  • Effective communication with all levels of staff across all departments and partners
  • Develop, apply, and report on department and regulatory metrics.
  • Any additional responsibilities as assigned by Scientific Affairs/Operations Management


Responsibilities:
  • 90% - Involved in all aspects of regulatory affairs from outlining the data requirements for new original applications.
  • Develops regulatory strategies, prepares and reviews dossiers for FDA submission including NDAs, ANDA’ s, Amendments, Supplements, and DMF’ s in line with regulatory requirements, regulatory guidelines, and GMP compliance.  Determines and approves data requirements, regulatory reporting categories, and gathers, assembles and reviews documentation and data from partners as needed to support submissions.
  • Serve as product regulatory expert for Product Development, Project Management, Marketing, Sales, Business Development, teams and partners 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.
  • Reviews, administers and approves change control process by reviewing proposed changes against most recent applicable filings to ensure regulations, guidelines, and commitments are satisfied.
  • 10% - Management of specific regulatory affairs programs and systems which may include:
  • Management of the procedures and process including training staff.
  • Manage quality systems within Regulatory Affairs including performance management metrics, standard operating procedures, documentation storage, database development and management for regulatory tracking.


Qualifications:
  • BS / Pharm D in Pharmacy, Biology, Chemistry, and Microbiology required. Advanced degree preferred
  • 3-5 years of regulatory affairs experience, focusing on parenteral dosage forms with emphasis on product development, product due diligence, regulatory strategy for new products and FDA communication.
  • Direct experience in preparing CTD format and electronic ANDA submissions to the FDA required.
  • Regulatory publication eCTD software experience preferred.
  • Solid knowledge of all aspects of regulatory pharmaceutical drug development process and life cycle management including strong command of CGMP’ s/FDA regulations, FDA Guideline documents, USP, ICH and other applicable laws.
  • Direct experience in preparing CTD format and electronic ANDA submissions to the FDA required.
  • Able to clearly articulate regulatory strategy at partner and project management meetings. Able to negotiate with partners to assure acceptance of regulatory strategy. Assures compliance with project team timelines and milestones.
  • Pharmaceutical development knowledge and understanding of various dosage forms, parenteral dosage forms preferred.
  • Experience in product due diligence for new development projects and in-licensing projects
  • Strong interpersonal skills, effective written and verbal communication, problem solving and decision making skills and ability to interact with all levels of management.
  • Experience successfully negotiating directly with the FDA, partners and internal teams.
  • Effectively prioritize workload and manage time to complete multiple projects within established timelines and goals with minimal supervision in a fast-paced environment.
  • Ability to work in a cross-functional team environment and a flexible team-oriented perspective.

Julie Monti
Senior Recruiter

Julie brings nearly 20 years of experience to her role as Senior Recruiter for The Steely Group. Throughout her career, she has built lasting relationships and strong partnerships while helping companies build successful teams. Julie is known for her sharp wit, easy smile, sense of humor and genuine interest in people.
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