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Director/Senior Director Regulatory Affairs
Lexicon Pharmaceuticals is currently recruiting for a Director/Senior Director, Regulatory Affairs to assume regulatory responsibilities for marketed products, including contributing to regulatory strategy for additional indications, managing all needed regulatory lifecycle management interactions and submissions, supporting post-marketing studies, maintaining labeling, serving as liaison with regulatory authorities, providing senior-level regulatory review of marketing, promotional, payor-directed, and medical materials to be used by the Commercial and Medical Affairs team. Lexicon may be flexible with the position location, however regular in-person collaboration will be expected in the New Jersey and/or Texas Lexicon offices.
The Director/Senior Director, Regulatory Affairs will be responsible for providing regulatory support for a broad range of programs and initiatives, with primary responsibility for the regulatory function for company assets at the peri-approval and approved/marketed stages, and secondary responsibility for assets at the development stage.
This role requires extensive hands-on regulatory experience and involvement, deep understanding of product labeling and promotional compliance, people skills, communication sensitivity, and exceptional collaboration and teaming capabilities. This position interfaces with many disciplines within the company including CMC, Clinical, PV, Medical Affairs, Marketing, Quality, specialty contractors and consultancies as well as functions within alliance partners such as Regulatory, Clinical, and Medical Affairs (for partnered programs).
This role will work effectively in a cross-functional manner to ensure that development and marketing stage activities are performed and deliverables produced are that are compliant with Health Authority regulations and guidance, and with industry standards and best practices, ultimately ensuring that regulatory submissions are prepared and submitted with completeness, quality and efficiency, receiving desired regulatory approvals, clearances and licenses. Specifically, the role requires strong capabilities in the areas of labeling preparation and negotiation, in the preparation of labeling supplements, and in the contribution to and review of advertising and promotional submissions for marketed products.
Key Responsibilities include but will not be limited to:
- Provide regulatory input to cross-functional teams responsible for assigned global development programs.
- Contribute to development of global regulatory strategy for compounds in development starting from pre-IND/IMPD/CTA to NDA/MAA submissions and additional claims designed to meet registrational objectives in a cost-effective and timely manner.
- Serve as primary contact with Health Authorities for assigned products, participate in (and lead, as appropriate) regulatory Health Authority meetings and prepare clear and accurate records of the interactions for internal use and submission to the Health Authority as needed
- Prepare and oversee submission of meeting requests, meeting background documents, scientific advice requests and responses to information requests with input from functional experts.
- Fulfill regulatory responsibilities per Lexicon procedures for assigned products, including development of the Target Product Profile, development and management of the label and associated documents (e.g., Company Core Data Sheet, Investigator Brochure), review and submission of periodic reports, review and approval of promotional and other product-related materials for release to the public, payors, and/or prescribers
- Provide project management for regulatory submissions to Health Authorities (including NDAs and sNDAs) in collaboration with Regulatory Operations team members including scheduling, oversight and review at the submission level and authoring and review at the document level
- Oversee internal subject matter experts, functions and external consultants, including CROs, in the preparation of regulatory documents and data submitted to regulatory authorities and ensure that the documentation prepared and submitted is complete, compliant and of the highest possible quality
- Serve as a company subject matter expert of regulatory guidance documents and Health Authority expectations, interpreting those for relevance and applicability to company development and marketing programs
- Develop, document and implement short- and long-term Regulatory timelines/milestones for key projects ensuring all timelines are detailed; dig down to specifics and clearly identify task owners for all submissions activities and compliance duties
- Direct and oversee day-to-day activities that track progress of multiple teams through managing project plans, resourcing, status-reporting, resolving issues, identifying project risks and accountability for deliverables across multiple functional organizations
- Bachelor’s degree in a scientific or medical discipline is required. Advanced degree is preferred
- Also Required:
- Minimum of 8-10 years’ experience in a regulatory position within a biotech, pharmaceutical, biopharma service provider / consulting or clinical research organization
- Extensive working knowledge, experience, and application of FDA guidance documents, MAPPs and other specifications and requirements, in particular for marketed (approved) products
- Extensive experience with labeling preparation, negotiation, revision and management
- Ability to develop rationale and compelling justification for strategic and differentiated labeling claims and language
- Experience with direct FDA interaction (or other regulatory agencies)
- Knowledge of global (US, EU and ICH) regulatory requirements and the ability to apply knowledge both strategically and operationally to marketed product regulatory issues
- Experience with Electronic Document Management Systems (Documentum, MasterControl, Veeva, other)
- Working knowledge and experience with eCTD viewing tools (Liquent, IQVIA, Lorenz, other) and other complementing eCTD publishing tools
- Experience with organizing, preparing and reviewing electronic submissions (eCTD)
- Working experience participating in a drug development team
- Proficiency with MS Office
- Excellent organization and multitasking skills
- Outstanding oral communication, written communication and presentation skills
- Ability to travel to and from New Jersey and Texas as needed.
- RAC certification is preferred
To apply, please visit the careers section of our website: https://lexpharmacareers.silkroad.com/.
For additional information about Lexicon and its programs, please visit www.lexpharma.com.
Lexicon is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
Lexicon Pharmaceuticals, Inc. is a drug-free workplace. Candidates are required to pass a drug test, background check and verification of credentials before beginning employment.
Job posted: 2022-08-04