Director overseeing the Fair Lending Program and Compliance Management System at The Bancorp Bank. This role leads compliance initiatives and supports regulatory oversight.
About the role
- Assistant Manager in Regulatory Affairs overseeing EU regulatory requirements and pharmaceutical registrations. Collaborating with teams and maintaining compliance in hybrid working environment.
Responsibilities
- Responsible for preparation / checking / review of pharmaceutical / quality part (all forms) of registration dossiers and variations /amendments / annual reports / renewals as applicable documents according to EU regulatory requirements.
- To identify and classify the changes as per EU regulatory variation guidance.
- To prepare response to regulatory deficiencies letters according to EU regulatory requirements
- To collaborate with other departments/partners
- To maintain lists/documents/records
- Responsible for keeping Orion internal regulatory system up to date and accurate
- To achieve his/her responsibilities within the agreed timescales
- To actively participate in the development of regulatory skills within the regulatory team by continuous up-dating
- Other possible tasks appointed by Supervisors
Requirements
- At least 8 years work experience in international regulatory affairs from Pharma industry and Confirmed knowledge of EU requirements and ICH guidelines , with Specific focus on product life cycle management.
- Experience in Formulations Analytical Development, Formulations Development or Pharmaceutical product development activities and eCTD submissions will be an added advantage.
- Fluency in oral and written English
- Ability to work well independently as well as in a team environment
- Task oriented with learning attitude and Team work skills
- Familiarity with Microsoft Office
Benefits
- An excellent opportunity to work in an inspiring and important role in the area of Regulatory Affairs
- Great opportunity to become part of the wholly owned subsidiary of globally operating Orion Group
- Possibility to utilize your own strengths with the support of the professionals
- Flexible, high-spirit working environment where your skills are appreciated
- Hybrid Work Policy (In a week - 3 days work from office and flexibility to work remotely for two times).
- Good work-life balance
- Clear, transparent processes and responsible supervisors are our benefits to the personnel
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Leads regulatory compliance for Fresenius Medical Care, ensuring adherence to laws and regulations. Collaborates with multiple departments for quality improvement in dialysis facilities.
Senior Legal Counsel II responsible for labor and employment legal aspects at Airbus. Leading investigations, managing labor relations, and supporting HR strategies across the US.
Onboarding & Compliance Specialist coordinating new hire processes and communications for Worldwide Flight Services in Seattle. Manage candidate interactions and ensure smooth onboarding for new hires.
Internal Regulatory Control Assistant supporting evaluation and improvement of internal processes at Betclic. Involving monitoring, reporting, and developing internal procedures in a dynamic environment.
Compliance Specialist managing regulatory compliance and audits for a financial institution in São Paulo, Brazil. Responsible for high - level regulatory inquiries and internal compliance training.
Senior Manager responsible for compliance with licensing and installation standards for Comcast security products. Collaborates with local teams to ensure adherence to industry regulations and best practices.
Senior Manager, Compliance overseeing compliance programs and initiatives at PayPal. Leading teams and fostering partnerships while driving continuous improvement in organizational compliance capabilities.
Senior Compliance Analyst conducting compliance assessments for PayPal and collaborating with business teams on regulatory guidance. Ensuring adherence to compliance regulations across various locations in the United States.
Regulatory Affairs Manager at Spectrum Vascular focusing on regulatory strategies and compliance for FDA and international medical devices. Collaborating with cross - functional teams to ensure timely submissions and approvals.