Regulatory Affairs Manager (Biopharma)

Job content

Consultys is a global engineering and services consulting company dedicated exclusively to the Life Sciences industry.

Since 2005, Consultys has been working on technical projects with some of the most sophisticated, innovative, and successful Life Sciences companies.

Our 650 consultants are working on innovative activities in engineering, production, quality (QA, QC, validation), R&D, and regulatory affairs across Belgium, Switzerland, Germany, France and Canada.

Thanks to our excellent team, we support manufacturers in all stages of drug development.

Respect, transparency, and gratitude.

These are the values that made Consultys one of the most high-performing Life Sciences consulting companies.

Do you want to be part of a human-sized company that values every individual?

Do you want to work on long-term innovative projects, working closely with global Life Sciences product companies in the world?

Join us!

We offer an attractive salary and benefits. You will work in a stimulating environment, with a lot of opportunities for your professional and personal development.

Your responsibilities:

• Responsible for defining Biosimilar regulatory strategies for assigned projects and programs and for obtaining project team alignment on those strategies
• Regulatory representative with a strategic partner(s) for assigned projects and programs and responsible for securing partner alignment on regulatory strategy
• Responsible for implementing defined regulatory strategies, including filing of all appropriate regulatory submissions for assigned projects and programs.
• Responsible for leading the coordination of all aspects of regulatory submissions relevant to assigned projects or programs
• Responsible for the development of core aRMMs and for leading their customization, submission, approval and dissemination across markets. Responsible for the implementation of updates to approved aRMMs
• Define Biosimilar labeling strategy, taking into account commercial and medical drivers. Align with strategic partners on labeling strategies. Manage the implementation with cross-functional teams and local regulations to ensure successful execution
• Discuss and align regulatory CMC strategies internally and facilitate alignment as needed.
• Provide regulatory support and guidance to supply & planning, quality, manufacturing, and logistics functions as needed
• Manage regulatory review of promotional materials, sales training materials and other external communications, negotiating regulatory compliance within established risk parameters including building business processes where necessary to train and audit affiliates and distributor teams and to approve pan-EU promotional materials
• Develop regulatory strategies to support the lifecycle management of products in line with business requirements
• Identify and assess regulatory risks associated with product development and lifecycle management. Assist in defining strategies to mitigate risks.
• Comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives and to ensure regulatory compliance
• Lead assigned process development activities, ensuring regulatory and cross functional alignment, training, and implementation as needed
• Build and maintain excellent relationships with relevant regulatory agencies, contractors, vendors and corporate partners while negotiating company position.
• Effectively lead communication and provide regulatory support on cross functional project teams to enable timely approval, implementation and launch for assigned projects
• Manage the day to day activities of assigned regulatory vendors
• Build strong relationships with affiliate and distributor teams to ensure the successful execution of their biosimilar regulatory responsibilities.
• Provide oversight and reporting on project progress to regulatory management.
• Prepare and deliver effective presentations for external and internal audiences.
• Provide regulatory guidance to company personnel for assigned projects and products throughout their lifecycle
• Monitor and analyze appropriate regulatory agency activities in areas of interest to the company and assess the impact on assigned programs.
• Supervise and/ or mentor designated regulatory team members, co-ordinating their activities
• Provide training and on-boarding support to regulatory colleagues

Your profile:

• 2-years’ experience in the pharmaceutical/biotechnology industry in regulatory affairs
• Preferred experience and knowledge in the preparation of regulatory submissions and supportive amendments or supplements
• Preferred knowledge of applicable regulations, regulatory guidelines and submission requirements and ability to interpret regulations and guidelines
• Foster effective, positive interactions with regulatory agencies, and corporate partners
• Some experience interfacing with relevant regulatory authorities
• Ability to represent the department in project teams, committees and external meetings to attain group goals
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
• Strong sensitivity for a multicultural/multinational environment and experience leading multi- disciplinary teams
• Ability to work independently with minimal supervision
• Demonstrate excellent communication skills: detail oriented, effective written and oral communication skills
• Demonstrate strong organizational skills, including the ability to prioritize personal workload and to manage a large volume of complex tasks