Senior Specialist, Regulatory Affairs

Travere Therapeutics; Schweiz; In loco; CHF 120.000 - 180.000; Tempo pieno

Descrizione del lavoro

Travere Therapeutics in Switzerland is hiring a Senior Specialist, Regulatory Affairs (EU/RoW) to support the preparation, submission and maintenance of regulatory applications, including CTA submissions and post-authorization activities.

You will work with regulatory leads, coordinate with external contractors, maintain document management systems such as Veeva Vault, and help implement process improvements across Regulatory Affairs.

Competenze

• Bachelor’s Degree/Science in a biological science is required.
• 4+ years regulatory affairs experience in pharma/biotech or government health agency.
• Good knowledge of the drug development process.
• Experience in ICH and EU guidelines for product development and submissions.
• Experience drafting regulatory submissions (CTA, MAAs, Variations).
• Independent, proactive, able to work in a biotech environment.

Mansioni

• Supports regulatory leads in preparation, submission and maintenance of regulatory applications (CTA, amendments, annual reports).
• Prepares high-quality responses to questions from regulatory agencies.
• Ensures submissions are complete, properly formatted and compliant with requirements.
• Interacts with regulatory authorities and coordinates with external contractors.
• Maintains document management and archival systems.

Conoscenze

Regulatory affairs

CTA submissions

EU regulations

Documentation

Cross-functional teamwork

Veeva Vault

Formazione

Bachelor's in biological science

Advanced degree preferred

Strumenti

Veeva Vault

Descrizione del lavoro

Department: 607000 Regulatory - TTSG Location: Rapperswil-Jona (SG), Switzerland

Be a part of a global team that is inspired to make a difference in the lives of people living with rare disease. At Travere Therapeutics, we recognize that our exceptional employees are vital to our success. We are a dedicated team focused on meeting the unique needs of rare patients. Our work is rewarding – both professionally and personally – because we are making a difference. We are passionate about what we do. We are seeking talented individuals who will thrive in our collaborative, diverse, fast-paced environment and share in our mission – to identify, develop and deliver life-changing therapies to people living with rare disease.

We stick by our values centered on patients, courage, community, and collaboration to pursue our vision of becoming a leading biopharmaceutical company dedicated to the delivery of innovation and hope to patients in the global rare disease community. At Travere Therapeutics, we are in rare for life. We continue to courageously forge new paths as we move toward a common goal of elevating science and service for rare patients.

Senior Specialist, Regulatory Affairs (EU/RoW)

Responsibilities

• Supports regulatory leads in the preparation, submission and maintenance of regulatory applications, including clinical trial applications (CTA), routine CTA amendments, pre & post authorization regulatory submissions and annual reports.
• Support regulatory leads in the preparation, review and submission of high-quality responses to questions to regulatory agencies.
• Ensures submissions are complete, properly formatted and comply with applicable regulatory requirements and timelines.
• Assist in interactions with regulatory authorities, including coordination with external contractors.
• Ensures document management and archival systems are maintained.
• May support Regulatory Operations with regional submissions.
• Coordinates regulatory project activities, tracks commitments, identifies risks and follows actions through to completion.
• Effectively collaborates with regulatory affairs counterparts to ensure submission goals are met.
• Research, interprets and communicates evolving regulatory requirements and emerging regulatory intelligence to support regulatory strategy and submission planning.
• Identifies opportunities to improve regulatory processes, tools and SOPs and contributes to continuous improvement initiatives across Regulatory Affairs.
• Supports various department activities

Education/Experience Requirements

• Bachelor’s Degree/Science degree in a biological science is required. Advanced degree preferred. Equivalent combination of education and applicable job experience may be considered.
• 4+ years regulatory affairs experience in the pharmaceutical or biotechnology industry or government health agency.
• Good knowledge of the drug development process is required.
• Demonstrated ability to independently assess regulatory issues, evaluate multiple sources of information, exercise sound judgement and develop practical regulatory solutions.
• Experience in interpretation and application of ICH and EU guidelines relevant to product development and submission of pre/post authorization applications.
• Experience in drafting and reviewing regulatory submissions (CTA, MAAs, Variations).
• Excellent interpersonal, communication, analytical, organizational skills, and level of accountability.
• Ability to manage various projects, solve problems, deliver on commitments and work with multidisciplinary teams.
• Independent, self-starting individual with a demonstrated ability to thrive in smaller, biotech environment is required.
• Must be able to prioritize and work effectively in an everchanging environment.
• Experience with document management/archival systems (Veeva Vault experience preferred)
• Some flexibility in hours will be required for participating in international teleconferences.

Additional Skills/Experience

• Embodiment of Travere’s Core Values: Courage, Community Spirit, Patient Focus and Teamwork
• Strong professional experience in a similar role within the pharmaceutical industry.
• Well organized with the ability to multitask, prioritize and manage shifting responsibilities in a dynamic, cross-functional teamwork environment.
• Excellent collaboration skills with strong attention to detail and the ability to multi-task and manage complexity.
• Strong interpersonal skills and excellent verbal and written communication skills are required.
• Ability to travel 10% domestically and internationally.
• If you require a reasonable accommodation to complete the application or interview process, please contact us by sending an email to [e-mail]. Please note that this email address is to be used exclusively to request an accommodation with the online application, interview or hiring process only. Travere HR will not reply to emails sent to this address for any other reason.

At Travere Therapeutics, we are in rare for life. We are a biopharmaceutical company that comes together every day to help patients, families and caregivers of all backgrounds as they navigate life with a rare disease. On this path, we know the need for treatment options is urgent – that is why our global team works with the rare disease community to identify, develop and deliver life-changing therapies. In pursuit of this mission, we continuously seek to understand the diverse perspectives of rare patients and to courageously forge new paths to make a difference in their lives and provide hope – today and tomorrow.

For more information, visit travere.com.