Regulatory Affairs Senior Specialist

MERCK
Posted on

Type

Executive / senior industry position

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  • Support in Preparation & submission dossier for post-approval variations (e.g. safety-related label updates, routine CMC changes such as shelf-life extension, change of manufacturing site), license renewal,
  • Act as point of contact to answer any question and activities related to operational / administrative tasks for preparation, submission and archiving of dossiers.
  • Ensure all technical aspects are covered to enable submissions to health authorities within agreed timelines.
  • Interact closely with and provides guidance to local/regional/global RA
  • Develop. maintain and support cleaning of databases for products
  • Maintain and update regulatory files and records as required; ensure appropriate archiving of all relevant documentation in the appropriate systems in line with applicable internal company standards
  • Support process improvements and implementation of best practices especially for archiving and other technical system.
  • Ensure compliance with local regulations and corporate policies and procedures as directed
  • Assist in preparation of regulatory deliverables (e.g. report generation, excel spreadsheets, power-point presentations)

 

Manage assigned regulatory tasks related to health authority notifications / submissions / registrations regarding new products, changes to products. Ensure regulatory strategy aligns with overall corporate regulatory strategy, goals and objectives. Carry out regulatory review of documents and changes. Carry out impact assessments where required. In this role you will also assemble and maintain files, and other regulatory documentation to ensure current, and changes recorded. Maintain library/database of standards and regulation. Review of updated regulations, Support preparation of and participate in any audits which require regulatory input. Respond to customer (internal & external) regulatory requests or enquiries.

 

  • Preferable experience working in medical device regulations,
  • Preferable experience working with Biological regulations 
  • Experience managing regulatory mitigation projects
  • Highly cooperative and collaborative
  • Experience in labeling activities including  submission mock up and artwork preparation (for D2)

Job Requisition ID:  197339 Working time model:  full-time

US Disclosure The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law.  This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.North America Disclosure The Company is committed to accessibility in its workplaces, including during the job application process. Applicants who may require accommodation during the application process should speak with our HR Services team at 855 444 5678 from 8:00am to 5:30pm ET Monday through Friday.

Job Segment: Medical, CAPA, Pharmaceutical, Database, Medical Device, Healthcare, Management, Science, Technology

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Posted on

Type

Executive / senior industry position

Cairo%2C%20Egypt

Cairo , Egypt