About the client:
Our client is a multinational company within the pharmaceutical industry.
Job description:
The RA Manager directs, coordinates, and manages the regulatory activities of the organization to ensure products are ready for market launch as quickly as possible. The RA Manager oversees regulatory processes for products requiring approval from Health Authorities, ensuring all necessary applications are filed and managed according to local regulations. The role serves as the key interface between the company and regulatory authorities, supporting the lifecycle management of medicines, and collaborating internally on drug development, manufacturing, clinical research, and marketing efforts.
Major Accountabilities:
Develop regulatory strategies and implementation plans for new product submissions based on business needs, and ensure timely documentation and submissions to regulatory agencies.
Provide expert regulatory input into strategic decisions, including portfolio review, prioritization, budgets, and external communications.
Prioritize submissions of new products and variations to maintain medicines throughout their lifecycle, ensuring compliance with regulatory standards.
Establish systems for publishing document submissions in hardcopy or electronic formats and stay updated on regulatory requirements for electronic submissions.
Review product artworks and marketing materials, ensuring they meet regulatory standards.
Develop and establish internal policies and standards, including the creation of Standard Operating Procedures (SOPs) as needed.
Manage regulatory budgets and allocate resources efficiently.
Liaise with Health Authorities to provide responses and represent the company in domestic or international regulatory matters.
Stay current with changes in regulatory legislation and guidelines, ensuring compliance.
Provide guidance to internal teams regarding product design, development, and marketing, and collaborate actively with other departments.
Participate in audits and regulatory agency inspections as needed.
Requirements:
Professional experience:
Solid experience managing regulatory affairs in the pharmaceutical industry.
Specific Knowledge:
Proficiency in MS Office (Excel, PowerPoint, Word)
Database management (OpenText)
Experience with e-CTD software (Liquent)
Education:
Minimum:
Degree in Scientific Disciplines (Pharmacy, Chemistry, Pharmaceutical Technology)
Preferred:
Master's in Regulatory Affairs or Management
Languages:
Fluent in English, and Portuguese (written and spoken).
