Associate Director, Regulatory Affairs - Halfway House
Merck & Co., Inc.
Major Activities Major activities include, but are not limited to: New MA applications for assigned products: Performs timely and correct submission and approval of assigned new Marketing Authorization applications in close cooperation with relevant persons in the managing, medical, finance, customer service, marketing and external affairs departments, GRA/RAI on sub-regional, regional and global level, as well as with local regulatory authorities as appropriate, depending on procedure type. Coordinates and implements early access programs with the Agency. Tracks process and manages answers to objections from the Agency on products registration and major new indications, involving negotiations to achieve best conditions. Designs and implements local action plans for new products, involving selection and regulatory training of external experts and closely interacting with the Agency and Advisory Committee members, with continuous interface with RAI, EEMEA regional liaisons. Maintenance of licenses for assigned products: Ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations and renewals, with a high standard and within the agreed timeframes and communicates approvals to stakeholders through the correct processes. For major indications, designs and implements local action plans as above mentioned for new MA applications. Compliance: For assigned products, ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, local physicians' circulars, packaging material and other applicable regulatory documents according to the company and local standards and Artwork Management procedures. Implement Prescribing Information within the correct timeframes for compliance. Ensures that all internal customers receive relevant information with regard to the regulatory status of the assigned products. Ensures the correct and proper utilization of AMS Blue to generate mockup artwork and to implement revisions to artwork. Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country. Ensures that files and archives related to Regulatory are kept updated and complete. Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with. Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance. Labeling and artwork: Ensures high quality translations and QRD check of Summary of Product Characteristics and Patient Package Leaflets including linguistic check of these documents. Ensures availability of packaging material, including package leaflets and all other artwork in a timely and correct manner and according to relevant Artwork Management procedures. Cross-functional activities: Obtains early information about new studies to be able to advice on Clinical Trial Applications and study planning as appropriate to the local GCTO group responsible for Clinical Trials. Ensures adequate support to other functions to enable compliance in areas related to regulatory, such as PSUR submissions and review of promotional material. Provides regulatory guidance and support to the license companies/joint venture/co-marketing partners as appropriate. Secures timely and adequate information and decision making with regard to regulatory issues that need to be brought to the attention of the Management Team, such as deletions, divestitures and acquisitions. Takes part in subsidiary product and launch teams to provide regulatory input and strategy advice. Participates, provides active input and lead if the case the local Medical Governance. Regulatory Policy/Environment: Keeps abreast of local and international laws. Through active participation in the regulatory work of the local Pharmaceutical Industry Association the incumbent seeks alignment of industry position with the company's interests. Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization and other stakeholders, and in concurrence with the Global & EEMEA Regulatory Policy lead. Participates in internal registration managers' meetings at sub-regional and regional level and EEMEA regulatory workgroups on selected issues. For new regulations, identifies and tracks changes/trends that might impact the company's business. Participates in task forces of Pharmaceutical Industry/Agency. Manage direct report, as applicable: Sets up priorities, organizes, oversees and monitors direct report's activities, towards division's and country's objectives achievement in compliance with policies and standards. Ensures that direct reports are trained for their proper use of internal regulatory systems. Through attendance to courses/workshops ensures that staff is appropriated updated on new legislations, requirements on Regulatory. Manages, coaches, and develops talent. Maintains a scientific knowledge and expertise for therapeutic areas of the company. Fosters a positive team spirit of the staff. Qualifications and Experience Required: Minimum BPharm or other life science or equivalent. A minimum of 5-10 years' Pharmaceutical Industry/Medical or Biotechnology experience. Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. Employee Status: Regular Relocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements: Hybrid Shift: Valid Driving License: Hazardous Material(s):
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