- American biopharma company focusing on rare diseases and orphan drugs
- Regulatory Affairs Director opportunity in Zug ,Switzerland
About Our Client
Our client is HORIZON THERAPEUTICS. They deliver medicines for rare, autoimmune and severe inflammatory diseases and provide compassionate support comes from their strong and simple philosophy to make a meaningful difference for patients and communities in need.
Headquartered in Dublin, Ireland, our client has locations in Europe, Canada, across the United States and a growing presence in Japan.
- In alignment with the Group Director, International Regulatory Affairs, responsible for developing and implementing regional regulatory strategies across Horizon's portfolio of medicines.
- Provide guidance on the content and suitability of regulatory documents for submission for the region. Performing critical review of submission documents to ensure compliance with regional regulatory requirements.
- Provide input into the response strategy to regulatory agency comments and questions
- Participate in regulatory agency inspections, as required.
- Effectively manage multiple projects and responsibilities concurrently
- Ability to thrive in a fast-paced innovative environment while remaining flexible, proactive, resourceful and efficient are essential.
- Ability to integrate cross-functional issues and balance competing priorities effectively
- Proven ability to communicate clearly and present key information objectively and collaborate effectively with management.
- Demonstrated ability to clearly and concisely communicate/ prepare presentations for all levels of management from executive to manager level.
- Under supervision from the Group Director, International Regulatory Affairs, leads and/or participates in meetings with EMA and/or Health Canada as appropriate. Oversees the planning and conduct of such meetings with regulatory agencies as appropriate.
- Ensures that systems are in place to establish and maintain regulatory compliance and deliverables.
- Develops and implements regional SOPs, as appropriate.
- Lead and oversee the preparation of local/regional product label according to local/regional regulatory requirements.
- Responsible for the monitoring and internal reporting of regulatory changes and requirements in the region in collaboration with the Director International Regulatory Affairs.
- Ensures regulatory compliance and overseas regulatory activities of 3rd parties (consultants and/or distributors) in the region, as required.
- Attend and actively participate in relevant industry associations on behalf of and in the best interest of Horizon.
The Successful Applicant
- Bachelor's degree in life sciences (pharmacy, biology, chemistry, pharmacology) or a related subject
- 8+ years of Regulatory experience in the Biotech/Pharmaceutical industry
- Solid working knowledge of regulations and guidelines governing drugs and biologics in development, including post-marketing in the EU
- Expertise in the EU region with global involvement would be preferred.
- Previous experience interacting with regulatory agencies is preferred.
- Experience with rare disease / biologics / orphan drugs is desirable.
- Experience in managing relationships with CROs and/or contractors also preferred.
- Outstanding leadership skills including excellent verbal and written communication skills, an innovative approach to problem-solving, and an integrated view of business and scientific issues
- Proficient in Microsoft Office.
- Professional, proactive demeanor
- Strong interpersonal skills
- Excellent written and verbal communication skills
- Fluent in English
What's on Offer
- Regional responsibility
- Competitive conditions