Manager/Director, Regulatory Affairs
Responsible for regulatory leadership, management, and strategic guidance for all regulatory aspects of new projects (INDs/NDAs, ANDAs) as well as marketed products. Combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Influence changing regulations and guidance, interface with outside regulatory agencies and trade associations and acts as an advisor/liaison to senior management in order to plan, evaluate and recommend regulatory strategy.
Scope of Authority
This is the senior Regulatory position in the company, with responsibility for the global vision, leadership and strategic guidance of the Generic Regulatory functions. This position provides expertise and guidance in interpreting US and international regulations and agency guidelines. The Director establishes internal policies to assure compliance, and partners with functional groups to define and implement strategies. The Director is accountable for Sungen regulatory performance.
% of Time
Ensure regulatory submissions are completed on time by working with project teams to gather the information and documents necessary to file complete and accurate submissions in accordance with corporate goals.
Develop and advance the organization's policy and procedures for regulatory affairs and compliance to establish a compliant culture
Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle
Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions
Develop global regulatory strategies and update based upon regulatory changes . Monitor evolving regulations, standards and governmental agency activities, interpret relevant information and take appropriate actions to inform and educate stakeholders and revise processes as necessary.
Strategize regulatory due diligence for potential and new acquisitions and advise executive management
Anticipate emerging issues and develop solutions to them
Develop corporate positions on regulatory risk-benefit
Create and develop product positioning strategies based upon regulatory requirements
Integrate regulatory considerations into the corporation's global product entry and exit strategy
Communicate application progress to internal stakeholders
Negotiate with regulatory authorities during the development and review process to ensure submission approval
Provide strategic input and technical guidance on regulatory requirements to corporate and/or management stakeholders
Ensure preapproval compliance activities are completed
Formulate company procedures to respond to regulatory authority queries
Ensure annual licenses, registrations, listings and patent information are maintained
Ensure compliance with product post-marketing approval requirements
Ensure advertising and promotional items are compliant to regulatory requirements
Review and approve publicly disseminated information to minimize regulatory exposure; review product claims, and preserve confidentiality of applicable product information
Oversee regulatory aspects of business relationships to ensure compliance and protect corporate interests
Ensure a system is in place to manage access to information requests
Provide regulatory input for follow-up to inspections and audits to minimize potential for findings of noncompliance
Identify and present option for risk mitigation to decision makers
Represent regulatory affairs in product recall and recall communication process
Ensure adverse events are reported to regulatory agencies and internal stakeholders
Act as liaison between the company and various governmental agencies, notified bodies, and international regulatory bodies
Ensure that regulatory expectations are clear to all internal and external stakeholders (including partners, CROs, consultants and contractors) in order to execute program objectives in compliance with applicable regulations.
Participate in applicable trade association/industry working groups to influence policy making in alignment with business strategies
Recruit, develop, manage and mentor regulatory professionals to contribute to organizational/human capital planning
Provide strategic guidance for resource and development planning
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
PhD or MS or BS science degree
Minimum 15 years Regulatory Affairs and drug development experience in the pharmaceutical industry
Minimum 10 years interacting directly with the FDA
Record of successful filings (INDs/ANDAs/NDAs) and interactions with FDA
10+ years managing groups
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
Thorough knowledge of FDA regulations, drug development, regulatory processes and principles
Often may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing etc.
Monitor costs of projects and of human and material resources within a department or unit
Monitor company-wide indicators such as market share and profitability
Develop least cost, least time means to provide optimal regulatory support for new products
Monitor industry trends and external environment in areas relevant to the assigned organizational unit.
Direct and manage the preparation of technical strategic regulatory documentation for agency submission.
Develop strong relationships with internal and external resources.
Demonstrated ability to maintain a collaborative relationship with the FDA
Critical thinking and problem solving, decision making, dealing with ambiguity, team building and motivating the team to action
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
Business travel is typically up to 10% of time; may exceed 10% as business needs dictate.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
We are a Pharmaceutical Development company located in Princeton, New Jersey.
Sat, 2 Sep 2017 11:59:40 PDT