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Senior Regulatory Affairs Associate

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Want to steer the growth of a major global brand? As a Senior Regulatory Affairs Associate you’ll have the freedom to show us what’s possible and help drive innovation that makes an impact. Globally.

 

Senior Regulatory Affairs Associate

Milano, Lombardia

Competitive Salary & excellent benefits package 

 

AS AN OTC REGULATORY AFFAIRS ASSOCIATE…

…..you’ll be part of a  team where outperformance and achievement are the common ground to build growth. You’ll have responsibility for deploying regulatory strategies and implement them across defined categories. Complying with Global standards and local procedures, you’ll help providing safe, effective and compliant products to customers, consumers and patients, as well as accurate, consistent and effective information to internal and external stakeholders.

 

SUMMARY OF RESPONSIBILITIES

The main objective of the role is to lead all the Regulatory Affairs activities on the assigned OTC brands, ensuring on time delivery of any project commitment, full compliance of activities and great effectiveness of claims and communication.

 

The OTC Regulatory Affairs Associate will focus on:

  • Regulatory Strategy: ensure that the pipeline is properly managed from a regulatory point of view, working with relevant Global departments and country team to support in defining the best regulatory strategy according to business needs, within agreed and tight timelines and focusing on competitive advantages to be brought to our brands. Act with high focus in overcoming local issues and constraints to ensure succesful product launches and keeping in mind financial considerations for regulatory budget management.
  • Regulatory compliance: ensure proper knowledge and expertise in managing independently the lifecycle management and all the compliance activities related to our brands (high quality product information translations, variations, renewals, submissions, update of RB databases and tracking sheets) taking care efficiently of accuracy in package preparation and administrative procedure
  • Understand and shape the regulatory landscape: monitor, collect, interpret and apply all relevant legislation, regulatory trends and regulatory guidelines in Italy and keep the Italian business up to date on national regulatory trends, risks and opportunities; provide advice to the business as necessary and assist in developing of strategies and action plans; 
  • Advertising: manage advertising process ensuring that promotional activities and materials are consistent with scientific ratio and meet applicable regulatory requirements. Active involvement in working on effective strategy to make our communication always more creative, efficient and attractive.
  • Liaise with local Health Authority about ongoing processes

 

Profile:

  • At least 4-5 years experience in Regulatory Affairs in a pharmaceutical company
  • Scientific Degree (Biology, Biotechnology, Pharmacy, CTF)
  • Fluent in English
  • Master in Regulatory Affairs - plus
  • Good understanding of OTC business
  • Personal skills: Positive attitude and enthusism, can-do approach, ownership and entrepreneurship, agility in dealing with complex tasks with a good level of authonomy
  • Good interpersonal skills in order to build good relationships with team and other colleagues, particularly with Marketing Dept.
Equality

In Return RB offer very competitive salaries with excellent benefits and the chance to progress your career within a truly global organisation.
RB is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other basis protected by appropriate law. All hiring decisions are made based on merit, competence and business need.


Job Segment: Pharmacy, Healthcare

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