Mallinckrodt Pharmaceuticals Associate Director, Strategic Global Labeling in Hampton, New Jersey
Associate Director, Strategic Global Labeling
JR000011284 Associate Director, Strategic Global Labeling (Open)
US Specialty Brand Headquarters - USA501
The Associate Director (AD), Strategic Global Labeling (SGL) serves as the regulatory contact for labeling on the global Regulatory Affairs (RA) sub team to ensure that labeling requirements are met for new and life-cycle products. Additionally, he/she is responsible for the development and maintenance of Company Core Data Sheets (CCDS), Prescribing Information and Patient Package Inserts, across multiple therapeutic areas in line with international standards and guidelines.
The AD will work independently across Regulatory Affairs. Plans and executes review of safety and non-safety related labeling changes. Demonstrates thorough understanding of applicable global regulations and effectively communicates same. Collaborates in the development of labeling within the Labeling Working Group (LWG), Labeling Review Committee (LRC) and related teams/committees and provides thorough and concise briefings for line management.
The AD may interact with global regulatory authorities. Effectively leads interdisciplinary teams.
Proactively participate in the strategic optimization of labeling documents via close scrutiny of company data, regulatory precedents and trends and competitor labeling.
Provide regulatory strategy and oversight of global labeling for assigned commercial products and development products.
Provide guidance to launch teams on launch strategy for new commercial products.
Lead label development, revision, review, approval and maintenance in compliance with CCDS, local requirements, business strategies, and overall quality.
Lead the Labeling Working Group (LWG) and Labeling Review Committee (LRC) to optimize label documents and promote cross-functional understanding of labeling dependencies.
Develop presentations to insure the information presented is suited to audience and desired outcomes.
Ensure the dissemination of LRC-approved labeling documents and supporting documentation; ensure quality of labeling deliverables (e.g., alignment of labeling text with data, regulatory requirements, consistency between labeling documents).
Contribute to the development of labeling processes.
Participate in any relevant continuous improvement efforts for labeling process.
Proactively participate in the implementation of the global labeling strategy including the development of target product labeling (TPL) for assigned products.
Experience / Skills:
Bachelor degree; advanced degree strongly preferred.
Eight (8) plus years drug/device development experience with three (3) years of experience in regulatory activities.
RAC certification desirable.
Experience leading teams.
Experience in developing and giving presentations
Mastery level knowledge of FDA guidelines and regulations with an emphasis on labeling activities.
Significant knowledge of global standards and regulations related to New Drug Applications, CCDS, and Product Labeling (US PI and EU SmPC experience required, other regional labels also preferred).
Thorough understanding of scientific principles and regulatory/quality systems relevant to drug development.
Models, inspires, and creates conditions for a respectful, highly ethical, and open work environment.
Excellent verbal and written communication skills as well as strong interpersonal skillsOp.
Ability to prioritize, manage multiple projects and meet project timelines
Ability to determine essential components of requirements in order to include them in applicable policies and procedures.
Demonstrates understanding of influencing others and is able to successfully negotiate solutions.
Ability to develop creative solutions to complex problems.
Excellent verbal and written communication skills as well as strong interpersonal skills
High attention to detail
Work effectively with minimal supervision
Reports to Senior Director, Strategic Global Labeling
Office based. May work remotely; however, 4 to 10 office days per month may be required depending on project needs.
Mallinckrodt is a global specialty pharmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.
To learn more about Mallinckrodt, visit www.mallinckrodt.com.
Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.
Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.