Associate Director of Regulatory Affairs
The Associate Director of Regulatory Affairs should have the ability to understand and evaluate competing perspectives and provide clear regulatory guidance based on internal and external guidelines. Key responsibilities are outlined below. Duties and responsibilities are not limited to the work listed below and may include other assignments as necessary.
Review and approval of product labeling (including all advertising and promotional materials)
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.
Review and approve product and process changes, as required, to ensure compliance with regulatory requirements.
Interpretation of product, policy, and process changes to ensure compliance with the regulatory requirements.
Assist with the creation and maintenance of regulatory documents and claims
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 representative with FDA, European Authorized Representative, and other regulatory agencies to obtain approvals as required.
Engage with regulators through the submission process, 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 strong and positive working relationships with OPDP reviewers.
Applies regulatory and therapeutic area knowledge to Brand Team’s objectives and initiatives to develop solutions to complex US promotional issues.
Regulatory review of post-market product changes and decision 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 decisions.
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 attendance of major PhRMA, FDLI, DIA, and other industry/FDA meetings.
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.
Education and Experience Qualifications:
Bachelor’s degree with a minimum of 7 years of experience in Regulatory Affairs, Labeling & Advertising Promotional Materials experience, or the equivalent in the pharmaceutical arena.
Extensive knowledge of regulations
Able to interpret regulations/guidelines/standards and make appropriate judgments on what requirements are applicable to products
Able to work on complex problems
Can easily adapt to a fast-paced environment
Can effectively communicate issues and ideas with peers and with management.
Has the ability to facilitate meetings with cross-functional teams.
Has a strong interpersonal, written, and oral communication skills.
Has the ability to build effective working relationships throughout the organization.