The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
MannKind Corporation is currently seeking a Sr. Manager, Regulatory Affairs to be located at our corporate headquarters in Westlake Village, CA or at our state of the art facility in Danbury, CT. The ideal candidate will be a well-rounded regulatory professional that is familiar with combination product submission, risk assessment, and regulatory strategy. This position will also be responsible for global regulatory strategy in collaboration with the product development team. This position will manage all pre and post-market submissions to the FDA. In addition, this position oversees all regulatory operational management of commercial materials (Veeva Vault electronic document management system) regulatory review and approval of all labeling, based on development and management of a target product profile (TPP) and submission of all materials to FDA, Office of Prescription Drug Promotion (OPDP) for respective products. This position requires an ability to understand and evaluate competing perspectives and provide clear regulatory guidance based on internal and external guidelines. Key job duties and responsibilities are as outlined below and will include providing strategic advice on submission strategy, pre-market (IND) submissions, advertising, and promotional activities for assigned products in accordance with business goals and objectives, FDA and global regulations/guidelines, PhRMA guidelines and company policy.
Develop submissions for existing products, clinical programs, and new product submissions.
Develop a strategy for new pipeline combination products
Provide review and approval of product and process changes, as required, to ensure compliance with regulatory requirements
Assist in developing and documenting sound regulatory decisions and justifications and advising the organization on the impact of changing regulations. Interpret product, policy, and process changes to ensure compliance with regulatory requirements
Review and approve product labeling (including all advertising and promotional materials) and participation in design reviews to ensure adherence to regulatory requirements as set forth in the CFRs
Develop, implement, and maintain procedures in support of regulatory compliance
Develop and manage TPPs for products, working with cross-functional disciplines
Assist with the development and implementation of regulatory labeling strategies for existing, new, and modified products
Assist with the creation and maintenance of regulatory documents and claims, and up-to-date (regulatory changes, business changes, new indications) labeling for products
Provide regulatory guidance, respective to labeling, to product core teams developing new products
Works with Regulatory Leadership as company representatives with FDA, European Authorized Representative, and other regulatory agencies to obtain approvals
Interface with regulators through the submission process, through industry associations and other forums to ensure corporate awareness of critical path requirements
Regulatory review of post-market product changes and decide on the appropriate mechanism for change control (e.g. internal documentation, notification of the change, supplemental submission)
Develop regulatory plans including rationale and internal documentation for regulatory assessments
Participates in FDA meetings as necessary for pre-submissions, branch meetings, clinical studies / INDs, and promotional materials
Maintains awareness of competitive activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted
Monitors US regulatory environment by reviewing regulatory and industry guidelines, untitled and warning letters to pharmaceutical companies, and by attendance at major FDLI, DIA, and other industry/FDA meetings
Oversee and manage staff responsible for all operational processes and procedures related to the review/approval of materials with the purpose of promoting, advertising, or providing information about the Company and the Company's products
Provide educational training for local regulatory staff, sales teams, contractors, and others regarding company policies and procedures within the scope of the Regulatory Affairs
Candidate to assist with additional regulatory projects as needed
Duties and responsibilities are not limited to the work listed above and may include other assignments as necessary
BS/BA Degree with 10 + years of experience or MS Degree with 8-10 years related experience or an equivalent combination of training and experience in the pharmaceutical industry
RN or PharmD preferred
Ability to understand, integrate, and effectively communicate the scientific/medical value of company products to the medical community and key internal audiences.
Excellent project management skills and experience in a multitasking environment
Strong MS Office 2003/2010 Suite skills (Word, PowerPoint). Applied document formatting and MS Word troubleshooting skills
Prefer experience with diabetes, endocrinology and/or metabolic drugs in a development capacity
Proven record of successfully delivering projects on time with the highest quality
Ability to work independently as well as part of a team environment
Proven ability to manage multiple projects, identify and resolve issues
Must be able to thrive in a fast-paced environment while remaining flexible, proactive, and resourceful
Excellent written and verbal communication skills, strong problem-solving ability, and attention to detail
Additional Salary Information: Base, Bonus, Equity and generous PTO!
Internal Number: SENIO01203
About MANNKIND CORPORATION
At MannKind, we’re focused on developing new ways for people to live fuller, healthier lives. Removing barriers to happiness. Helping everyone experience the best of what the world has to offer.
That focus extends to our culture. We are proud to be a part of an inspired community, fueled by the diverse experience and ideas of our people and partners.