Mallinckrodt Pharmaceuticals Senior Associate Regulatory Operations Publishing in United States
Senior Associate Regulatory Operations Publishing
JR000007379 Senior Associate Regulatory Operations Publishing (Open)
US Specialty Brand Headquarters - USA501
SUMMARY OF POSITION:
The Regulatory Operations Sr Associate, Publishing will be part of the Regulatory Operations Publishing Group and will coordinate the publishing process with Regulatory Affairs (RA) to ensure timely and accurate submissions to the FDA and other agencies. This includes, but is not limited to, creation of templates, profiles, and styleguides to specifications, training new users, independent publishing of complete eCTD, NEES, and other submissions, and review of other group members’ output.
Coordinates publishing efforts for all submissions to FDA and other global health authorities. This includes, but is not limited to, creation of templates and profiles within InSight Publisher according to RA and FDA specifications; management of documents within Documentum; assembly of submissions through the use of established templates and guidelines ; and XML backbone generation for electronic submissions. Lead reg ops effort for assigned publishing project within the regulatory and company project team, which include timeline mgmt., partner with content authors, and regulatory lead Support the use of the submission document mgmt. system Responsible for managing the quality of all eCTD submissions. Reviews work of RA Operations Associates and Specialists to ensure accuracy and compliance of work produced. Attends Publishing Group and RA meetings and interacts closely with department members. Assists RA in interpreting FDA and ICH guidance as it relates to the established CTD templates, in addition to numerous other submission types (e.g. NDA, ANDA, IND, DMF, PSUR, Annual Reports, Pre-Meeting Packages). Maintains knowledge of current regional regulations in regard to application format. Assesses impact of regulation changes to current work procedures and SOPs. With the Manager, updates procedures and SOPs as appropriate and trains personnel regarding all revisions. Anticipates Regulatory consequences to changes in application format, and works with RA to ensure all documentation both received and generated is accurate.
DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:
Attend seminars and courses to maintain career growth and to stay updated on changes to Agency guidance.
Other duties as assigned with or without accommodation.
Education required/ preferred:
Minimum of a Bachelor degree from an accredited college or university.
5+ years experience with electronic submission software and/or other related industry specific software.
Knowledge of ICH and FDA guidance/regulations.
Ability to set and manage multiple priorities and projects to complete tasks within established timelines.
Excellent interpersonal, oral, and written communication skills.
Able to work with multiple groups of people at one time.
Proficient with Microsoft Office & Project
Must be detail oriented.
Must be able to adapt to changing priorities and be a fast learner.
Must be able to set and manage multiple priorities and projects to compete tasks within established timelines.
Must work well under tight and conflicting deadlines.
Strong analytical and problem solving skills.
Must be able to work with minimal supervision.
Must be able to prioritize own work effectively.
Strong interpersonal skills, including ability to remain calm, professional, diplomatic, and positive.
Allocate down-time effectively.
Must have exceptional interpersonal skills and be able to interface with all departments and associate levels. Flexibility to accept new duties as assigned
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.