Company Description
At LEO Pharma , we are at a pivotal point in our transformation journey to advancing medical dermatology by developing new biologics, in a mostly unexplored therapeutic area in the world today.
Every day, we seek inspiration from people living with skin diseases. We are passionate about identifying and addressing their greatest health needs, to both advance medical dermatology and help them live fulfilling lives.
As a purpose-driven company, high performance is measured equally as sales results and the positive impact we create - for health care professionals and their patients. These aspirations are encapsulated in our perpetual quest for the world's best talent.
Job Description
As
Regulatory Affairs Specialist you will have responsibility to positively contribute towards managing regulatory activities in the local market, as per assigned responsibilities, including Clinical Trial and Marketing Authorization applications.
The roll will ensure local regulatory strategic insights and optimal pathways to drug development; including relevant local regulatory intelligence. Secure essential interface with Regional Leads.
Responsibilities:
- Responsible for executing specialized projects or activities essential to the achievement of overall functional objectives;
- Support to the preparation of regulatory applications to the Local Health Authority;
- Maintenance of existing Clinical Trial (where applicable) and Marketing Authorizations;
- Submission of the Clinical Trial Application of new clinical protocol and amendments in the local web portal according to the national requirements.
- Work in accordance with regulatory systems and processes;
- Legal, Medical & Regulatory (LMR) activities for promotional and non-promotional marketing materials, with supervision;
- Proactively secure a constructive regulatory collaboration in the interface with Commercial, Customer Order Management (COM), Global Product Supply, Global Quality Assurance (QA), Pharmacovigilance (PV), Global Public Affairs and Marketing Compliance and other key areas of the business;
- Preparation and maintenance of text for product packaging, patient leaflets, SmPCs, etc.;
- Regulatory intelligence and networking: Contact with Regulatory Authorities, Trade Associations and other pharmaceutical companies, including attendance at external meetings. Reading of journals and other published articles;
- Review of new legislation when issued, and sharing information with key stakeholders, as applicable;
- Creation of local regulatory documents in eDOC LEO, as applicable;
- Administrative responsibilities, as required for the role, according to LEO Pharma QMS processes and procedures;
- Monitor and assess new and revised regulatory legislation and guidelines relevant to the roles and responsibilities of the position;
- Communicate new requirements with potential global impact to Regulatory Intelligence Department and relevant stakeholders, including GRT and local affiliate;
- Contribute to ad hoc regulatory projects, as applicable for the market, with some supervision;
- Support constructive and transparent working relationships with the Local Regulatory Authorities and trade associations;
- Effectively communicate, both internally and externally, to key stakeholders, on matters of varying complexity;
- Active participation in RA working groups, as applicable;
- Development of proposals to enhance existing processes and practices;
- Deputize for the Senior RA Professional, or other team members, on an ad hoc basis, including representing LRA at global and external meetings.
Qualifications
- Degree in Life Sciences, Pharmacy or equivalent experience.
- Relevant experience in Regulatory Affairs and a good understanding of the drug development process and life cycle management.
- Familiar with submission portals, electronic document management systems, electronic Review Systems (e.g. Veeva, eRIMS, eDOC and MyDoc) and IT systems (eg MS Word, Excel, PowerPoint, Visio, Lotus Notes and Outlook).
- Stay abreast of scientific and relevant regulatory updates.
Other skills
- Ensures accountability
- Proactive and energetic attitude
- Collaborates cross functionally
- Communicates effectively
- Decision quality
- Attention to details
- Being resilient
Additional Information
Please note that we review applications and conduct interviews on an ongoing basis.
|
