Manager, Regulatory Affairs
Adare Pharma Solutions, Italy
Job Description
Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare! We work closely with our pharmaceutical industry partners during all phases of drug development and commercial manufacturing with a mission of improving the lives of patients and medicines essential to people all over the world. Every role within Adare offers you a unique, customized experience with a chance to make a real impact that is critical to our success. With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!
Join our mission at Adare!
What can Adare offer you?
- Health Insurance
- Pension Plan
- Benefits
- Performance-based bonus and Long-Term Incentive Plan
We are seeking to hire a Manager, Regulatory Affairs to join our Regulatory Affairs Team
JOB SUMMARY
Manager, Regulatory Affairs is responsible for the regulatory aspects related to the product development, registration, and marketing of the Company’s products under responsibility and for oversight of regulatory affairs at the European manufacturing facilities. This position is reporting to the Global Head of Regulatory Affairs and Pharmacovigilance/Exec. Director. Such support is provided through the identification, implementation, and management of regulatory strategies, preparation of regulatory documents for the filings, interactions with consultants and regulatory authorities. Other responsibilities are linked to the GMP area, through the definition and implementation of activities to support commercial products. The Manager, Regulatory Affairs hires, develops, and manages direct reports, is responsible for regulatory service providers, and manages departmental financial activities.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Provides regulatory leadership in support of the development, registration with local and international health authorities, and maintenance of products under responsibility.
- Develops and implements short and long term regulatory strategies to achieve product development goals, product approval, and to support life cycle management projects for commercial products under responsibility.
- Ensures that all strategic and tactical activities are conducted in accordance with applicable regulations per local and international health authorities and working closely with the internal departments and across project teams.
- Ensures clear communication of project activities and progress in a timely manner.
- Oversees the planning and coordination of regulatory submissions and regulatory agency meetings.
- Manages and oversees the preparation and filing of regulatory submissions to support new product approvals and commercial products (including labeling).
- Authoring eCTD submission and managing regulatory change controls working with internal and external partners.
- Provide regulatory support to MAH for their applicable dossier file.
- Ensures submissions are complete, properly formatted, and comply with applicable regulatory requirements.
- Serves as a key contact with Health Authorities and facilitates communication between Health Authorities and the project team.
- Ensures timely and appropriate regulatory management of changes to products for CMC, clinical, and labeling.
- Manages contracts with regulatory consultants/vendors/partners in Europe.
- Supervises regulatory vendors.
- Manages the departmental budget definition process in Europe.
- Ensures compliance in departmental budget execution.
- Maintains a high level of professional expertise through familiarity with guidelines, scientific literature, and participation in training courses.
- Leads the selection process to hire direct reports and oversees the performance, training, and development of direct reports.
- Carries out his/her work in compliance with company procedures and in accordance with the provisions of the occupational health and safety management system and Good Manufacturing Practices.
- Works effectively under deadlines.
- Acts as the company’s representative by showing respect and being an ambassador for the established beliefs and behaviors of the Company.
- Participates in the development and implementation of methods, procedures, and regulations necessary for the smooth operation of the business.
- Respects policies, procedures, and regulations in force in the company.
- Completes assigned tasks in a safe manner and in a constant state of alertness.
- Upholds Company policies, including the Ethics and Conduct Code.
- Works in a cooperative manner with managers, supervisors, coworkers, customers, and the public.
- In particular, with regard to health and safety at work, b