Regulatory Affairs Senior Consultant
We are looking for a Regulatory Affairs Senior Consultant to support our Regulatory Affairs Department in the registration and maintenance of pharmaceutical products (both finished products and active pharmaceutical ingredients) in Russia.
The resource is expected to provide independent regulatory guidance to product development in strategic planning, pre-marketing, submissions and to support product launches on the Russian market. The individual leads the submission of licenses and authorizations for the registration and maintenance of pharmaceutical products for the Russian market. The RA Senior Consultant helps to define data and information needed for regulatory approvals in conjunction with our Regulatory Affairs Department. The role assists in the development of best practices for Regulatory Affairs processes.
- Ensures compliance with regulatory agency regulations and interpretations.
- Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.
- Involved with the preparation of necessary outlines, summaries, status reports, project reports, memos and slides.
- Provides solutions to a variety of problems of moderate scope and complexity.
- Researches, collects data, and responds to requests from regulatory agencies and/or clients to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information internally and to clients.
- Prepares regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance requirements.
- Provides regulatory guidance to product development teams and responds to product information requests.
- Performs GAP analysis of API and finished product dossier for the Russian market.
- Leverages scientific and technical understanding of regulated products to provide regulatory input to product lifecycle management and evaluate regulatory impact on products.
- Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with customers’ business objectives.
- Engages with local and/or regional regulatory agencies.
- Deliver by acting with speed, flexibility, accountability and appropriately managing priorities to deliver results for on-time clearances.
- Bachelor degree from accredited college or university in science, chemistry, biology, pharmaceutical biotechnology, pharmacy, medical / scientific writing.
- At least 4+ years of regulatory affairs or related/equivalent experience
- Experience with domestic regulatory submissions is required.
- Experience with or exposure to foreign regulatory submissions
PROFESSIONAL EXPERIENCE REQUIRED:
- Russian: native speaker
- Fluent English (mandatory)
If interested, please send your resume in English to firstname.lastname@example.org Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order to succeed in a challenging business environment, and we are committed to providing practical processes and programs to identify, develop and inspire all our current and future leaders.