Johnson & Johnson Careers

Regulatory Affairs Lead

Kyyivs'ka, Ukraine
Approval Liaison


Job Description

Requisition ID: 1905731453W

Janssen, pharmaceutical division of Johnson & Johnson is looking for a strong candidate with communication and interpersonal skills, team-oriented, self-motivated, multi-task management and problem-solving abilities for Regulatory Affairs Lead (RAL) based in Kiev, Ukraine
 
Job Purpose:
RAL ensures products of area of responsibility meet corporate & country regulatory requirements by supporting all assigned regulatory aspects of product approval, license renewals and post-marketing compliance. Responsible for preparation of document packages for regulatory submissions ensuring compliance with local and international regulations/ interpretations. RA Lead will be expected to interact with all functions within company as necessary. RA Leader will be expected to interact with external contacts as necessary including maintenance and tactical level communications with Regulatory Authorities. 

Responsibilities

  • Develop regulatory strategy that aligns with business strategy, defines submission requirements and requests necessary data, information, and documentation from other departments
  • Work closely with regulatory, market access, PV, marketing, legal and other professionals across the company to develop & implement company-wide programs and processes for regulatory affairs compliance within arear of responsibility
  • Scan the external environment and monitoring changes in the regulatory framework of regulatory processes to proactively adapt regulatory strategies and influence change working in the trade associations within areas of responsibility, identify regulatory trends and their implications for company
  • Plan regulatory milestones, set timelines and assure timely, accurate and complete submissions to national regulatory authorities
  • Ensuring accuracy, scientific validity and optimal presentation of submission documents that meet current best practice standards
  • Registration dossiers preparation for the submissions, variations and renewals and their submission to the competent national regulatory authorities: communication for receipt of dossier, preparation of mock-ups, local SmPC, dossier compilation, order and receipt of samples and standards, dossier & samples submission, follow up with RA in all levels, etc.
  • Taking the necessary measures to ensure compliance with the planned timing of new product registration, renewal and variations traded products
  • Communicating with Regulatory Authorities to expedite review and approval of submissions
  • Maintains records on legislation, regulations and guidelines
  • Safekeeping of documents archive in coherent order
  • Ensuring compliance of label creation process with local regulations
  • Responds to RA information requests
  • Assists in the review of promotional items
  • Educate, train and advise company professionals to ensure compliance with RA requirements
  • Management of RA staff (one subordinate)
  • Providing regulatory advice to teams on assigned projects

Qualifications
  • Bachelor’s Degree in a related field such as: Pharmacy, Medicine, Biology or Chemistry;
  • 3years + of experience in Healthcare, Pharmaceutical (preferable) industry;
  • Clear understanding of current pharmaceutical regulations for RX products in UA & international regulatory legislation/requirements, RA procedures, fundamentals of GMP, GLP and GCP
  • Excellent verbal and written communication and presentation skills with the ability to communicate in English in an easy to understand manner
  • Proficiency in Microsoft Office Products, namely Word, Excel, and PowerPoint
  • Strong analytical skills
  • Ability to prioritize, plan & evaluate deliverables
  • Ability to independently resolve straightforward issues and identify proposed strategy for complex issues
  • Good interpersonal skills required to build relationships with and influence internal departments and externally with Regulatory Authorities.
  • Ability to work in a fast-paced environment
  • Ability to successfully manage multiple priorities are keys
  • Proven ability to work effectively on diverse, cross-functional teams
  • Able to work with a high level of autonomy and independence

Primary Location
Ukraine-Kyyivs'ka--
Organization
J&J Ukraine (8434)
Job Function
Approval Liaison
Requisition ID
1905731453W