Associate Director/Director, Regulatory Affairs

Company: MannKind Corporation

Position: Associate Director/Director, Regulatory Affairs

Location: Company headquarters in Westlake Village, CA

Posted: November 17, 2020

At MannKind our employees are our number one asset, and we continue to be a tight-knit community where each of us has a critical role in our success. Committed to diversity, at MannKind we depend on a rich blend of ideas, backgrounds, and working styles in our quest to change the world for the better.

Position summary:

MannKind Corporation is currently seeking an Associate Director/Director, Regulatory Affairs located at our corporate headquarters in Westlake Village, CA. 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 the 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.

Principal responsibilities:

  • Develop submissions for existing products, clinical programs, and new product submissions.
  • 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 organizations 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
  • Review and approval of labeling and marketing collateral to ensure substantiation of claims, adequate information, and cautions/warnings are present and that all labeling is in conformance to regulatory requirements in accordance with Federal, state, and other applicable regulatory and quality requirements
  • 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
  • Oversee or manage interactions with OPDP regarding advertising and promotion for assigned products. Establishes a strong and positive working relationship with OPDP reviewers
  • Applies regulatory and therapeutic area knowledge to Brand Team's objectives and initiatives to develop solutions to complex US promotional issues. Ensures regulatory compliance while effectively managing business risks
  • 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 non-filing decision
  • Provide promotion integrity advice and guidance on the development of the draft labeling to ensure commercially viable US labeling upon which future promotion and advertising will be based
  • Participates in US labeling negotiations and FDA meetings as necessary
  • Ensures that changes in US Prescribing Information are reflected in current promotions and advertising
  • Understands global promotional strategies and provides solutions to local US regulatory promotional issues
  • Maintains awareness of competitive activities by monitoring major US Medical meetings where assigned therapeutic area products are promoted
  • Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical companies published by OPDP, and by the attendance of 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 Advertising, Promotion
  • 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

Education and Experience Qualifications:

  • Bachelor’s degree with a minimum of 7 years of experience in Regulatory Affairs with demonstrated submission success, Labeling & Advertising Promotional Materials experience or a closely related discipline in the pharmaceutical arena
  • Thorough knowledge of global regulations
  • Able to interpret regulations/guidelines/standards and make appropriate judgments on what requirements are applicable to products
  • Able to work on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors
  • Ability to adapt to a quickly changing environment
  • Ability to effectively communicate issues and ideas with peers and with management
  • Ability to organize and lead meetings with cross-functional teams
  • Demonstrated interpersonal, written, and oral communication skills
  • Ability to build effective working relationships throughout the organization
  • Effective communicator
  • Must be able and willing to work diligently in a high-visibility, fast-paced environment with changing timelines and priorities and exhibit a passion for patients

MannKind Corporation (NASDAQ:MNKD) focuses on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. MannKind is currently commercializing Afrezza® (insulin human) inhalation powder, the Company's first FDA-approved product, and the only inhaled rapid-acting mealtime insulin in the United States, where it is available by prescription from pharmacies nationwide. MannKind is headquartered in Westlake Village, California, and has a state-of-the-art manufacturing facility in Danbury, Connecticut. The Company also employs field sales and medical representatives across the U.S. For further information, visit www.mannkindcorp.com.

Mannkind Corporation is proud to be an Equal Employment Opportunity employer. We provide equal employment opportunity (EEO) to all persons regardless of race, creed, color, religion, national origin, ancestry, gender (including pregnancy, breastfeeding or medical condition related to pregnancy or breastfeeding), age, physical or intellectual disability, sexual orientation, gender identity, gender expression, gender stereotyping, marital status, military or veteran status, citizenship, genetic characteristic or information, or any other characteristic protected by applicable federal, state, or local law.