Regulatory Affairs Manager (for Ireland and Malta)
Regulatory Affairs Manager
At Ferring Pharmaceuticals, we help people around the world build families and live better lifes. We are entrepreneurial and innovative, with a global team focused on scientific advances in the areas of reproductive and women’s health, gastroenterology and urology. Ferring + You is all about working together and sharing ideas, so that we can bring science to life for patients around the world.
Every person at Ferring works together to change lives and help people build families. Our corporate teams offer empowering, innovative, challenging and rewarding careers – we are motivated to make a difference. To reach our full potential we collaborate, and respect and value diverse contributions so that we can grow as an organisation and as professionals. Together we can influence the world around us to make life and work better.
As Regulatory Affairs Manager your role will be to ensure Regulatory, Safety and Quality compliance for products on the Irish and Maltese markets
Your day at Ferring
Preparation, review and submission of variations, renewals, new product authorization applications and any other regulatory submission as required.
Prepare regulatory strategies and contribute to business decision making in relation to product launches and product changes.
Market compliance: Overall local regulatory and market compliance.
Pricing: Involved in product price approvals, product launch preparation and maintenance of the “Prices in Market” database.
Manage regulatory files for Malta: Oversee the review and approval of regulatory submissions for Malta, in line with regulations.
Surveillance: monitor changes in regulatory requirements and take appropriate actions when required.
Oversee the regulatory information in the global database to ensure that the data reflect the current registration status for product in the assigned therapeutic area(s).
Prepare regular reports for accomplishments, ongoing projects and KPIs in the region.
Ensure the development, implementation, and compliance of relevant SOPs for Regulatory Affairs. This includes contribution to improve RA processes at regional and local level.
Support and backup the UK Regulatory Affairs employees, as required.
Timely, scientific responses to the medical information queries placed, where Ireland specific input is required.
Product Quality Complaints
As Local Complaints Co-ordinator:
Process complaints according to local and corporate procedures.
Liaise with the complainant.
Local Quality Management System
To manage and ensure that the local QMS is kept active and updated, to ensure local market compliance with corporate, regulatory and legal requirements.
Quality Responsible Person (QRP) and Key User for SOPs as defined in the relevant SOPs
Internal Auditor. Audit preparation and providing response to audit findings.
Analysing risks that could damage the quality of a product.
Liaise with internal colleagues and external contacts as required.
Act as the GDP Responsible Person’s (RP) point of contact.
Ensure compliance with GDP requirements.
Ensuring QMS is implemented and maintained, focusing on the management of authorised activities and the accuracy and quality of records
Ensuring that initial and continuous training programmes are implemented and maintained.
Coordinating and promptly performing any recall operations for medicinal products
Ensuring that relevant customer complaints are dealt with effectively
Ensuring that suppliers and customers are approved
Assessing any subcontracted activities which may impact on GDP
Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place
reviewing transport records and temperature excursion reports
Providing relevant information to the GDP Responsible Person and communication of the Responsible Person’s decision on the final disposition of returned, rejected, recalled or falsified products
Ensuring that any additional requirements imposed on certain products by national law are adhered to. The RP has the authority to take decisions with regard to these responsibilities.
Review Standard Operating Procedures (SOPs), Policies and other related documents
As Local Recall Responsible Person:
Management of local procedures.
Ensure recalls are carried out effectively and efficiently according to corporate and local requirements.
Timely performance of the recall process including Global Quality Assurance notification as per Corporate SOP
Perform yearly mock recall if no recall occurs.
- Support audits and any Health Authority inspections
- Be part of the Internal Auditor team
Contribute data to regular Regulatory Affairs and PV reports
Back Up Roles
- Local Recall Responsible Person UK back-up
- Product Complaints: Local Complaints Co-ordinator UK back-up
- In all aspects of the role, adhere to GDP/GPvP regulations
Behind our innovation…There’s you
BSc from a Life sciences/scientific background
Min 3 years Regulatory experience related to Medicinal Products
Strong scientific/medical background
Project Management; Planning/organisation skills
Attention to detail
Team player and a self-motivator
Excellent written and oral communication skills
Flexibility, ability to multi-task
Good scientific writing skills
Excellent communication skills and a team player
Clear and accurate record keeping
People come first at Ferring
Get inspired from our commitment to advocate for everyone’s right to build a family, no matter who you are, where you live or who you love
Our inclusive support package – “Building Families at Ferring” provides equal and accessible policies for all employees who wish to start their family journey, ensuring a global standard, irrespective of location and role
Parental leave for both birthing and non-birthing parents
Extended support on family building journey
Making a difference in the life of millions of people means we succeed by working together. Our diverse backgrounds, experiences, expertise, and perspectives enable us to find solutions to even the most challenging problems, and our success is tied to each team member’s contributions. Imagine the power of your career when it’s Ferring + You.
Behind our purpose… There’s you
If our mission and your vision are aligned, please apply!
We strive to build and maintain an inclusive and diverse workplace with equal opportunities and mutual respect for all employees regardless of their backgrounds and socioeconomic status.