On behalf of our client, Johnson & Johnson, we are now looking for a Senior Regulatory Affairs Specialist for a consultant assignment with the initial duration of 6 months. The office is located in Uppsala, but the work can be done remotely from anywhere in Sweden. We are looking for someone who is available to start by the end of February.
International Registrations: You will be responsible for registration activities related to new product development, new product introduction, renewals and post approval changes for Asia Pacific, Japan, Latin America and Europe, Middle East, and Africa.
* 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, memos, graphs, charts, tables, 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 distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates
* Provides regulatory guidance to product development teams and responds to product information requests
* Provide Regulatory Affairs support during internal and external audits
* Assists in the development of best practices for Regulatory Affairs processes
* Represents Regulatory Affairs on cross-functional project teams
* Adheres to environmental policy and procedures and supports department environmental objectives.
Qualifications and Experience:
* A minimum of a Bachelors degree with at least 4 years of working experience within a regulated environment or equivalent is required - preferable medical device.
* Excellent written, verbal communication and presentation skills is required.
* Knowledge of US and EU regulations is preferred.
* Experience in the preparation and submission of international regulatory filings is preferred.
* Previous experience working with cross functional teams within a matrix environment is required.
* Swedish speaking is preferred.
* Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products is preferred.
* Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives is preferred.
* Consults with others to understand the benefits, risks, and Credo-based impact associated with decision alternatives before making decisions is required.
* Provides support to projects of medium complexity and ensures timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance is required.
* Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations.
* This role is to be based in Uppsala, Sweden and will require up to 10% domestic and/or international travel.