Senior Manager, Regulatory Affairs

Summit Therapeutics, Inc.; Dortmund; Remote; EUR 70.000 - 90.000; Vollzeit

Zusammenfassung

A biopharmaceutical company is seeking a Senior Manager of Regulatory Affairs to support regulatory activities for assigned projects. This role involves managing submissions to regulatory agencies, providing guidance internally, and ensuring regulatory compliance. Candidates should have at least 3 years in regulatory affairs and a degree in a relevant field. The position is primarily home-based in Germany.

Qualifikationen

• Minimum 3+ years of experience in Regulatory Affairs.
• Minimum 7+ years of experience in pharmaceutical, biotechnology or life science industry.
• Knowledge of EMA and European regulations and guidelines.

Aufgaben

• Support the day-to-day regulatory activities of assigned projects.
• Manage the regulatory submission processes and timelines.
• Provide regulatory guidance internally on study-team decisions.

Kenntnisse

Strong written communication

Interpersonal skills

Detail-oriented

Organizational skills

Proactive work style

Ausbildung

BA / BS degree in biological or health-related sciences

Master’s, PhD or PharmD

Tools

MS Office suite

Electronic document management systems

Jobbeschreibung

Overview of Role

Reporting to European Regulatory Director, the Senior Manager of Regulatory Affairs will support the day‑to‑day regulatory activities of assigned projects. These assigned projects include support of preparation and compilation of submissions for regulatory agencies, tasked clinical studies, management of regulatory submission processes and timelines, regulatory tracking tools, archives, and infrastructure, as assigned.

• The role is primarily home based out of: UK, Ireland, Germany, Belgium, Netherlands, Switzerland

Role and Responsibilities

• Provide ownership of projects and activities, including clinical trial applications (CTAs) and other European focused MAA pre‑submission activities.
• Contribute and drive the regulatory content and strategy for marketing authorization submissions and pre‑MAA submissions
• Provide regulatory guidance internally on study‑team decisions
• Update study / project teams of regulatory activities in the context of study team management meetings
• Manage and track queries, commitments and submissions with reference to regulatory agencies, collaborate with subject matter experts to provide responses as necessary, provide periodic status updates regarding unfulfilled conditions / commitments
• Collaborate with cross‑functional study team for planning of regulatory documents, including health authority meetings such as scientific advice, pediatric and / or orphan designation.
• Contribute to, or lead, internal meetings such as kick off meetings, cross functional project updates
• Manage / Support internal document processes, including reviewed, finalized, signed‑off, and archiving
• General support of global / other region regulatory submissions and strategic planning as applicable
• Contribute to / and track regulatory compliance pre and post approval
• All other duties as assigned

Experience, Education and Specialized Knowledge and Skills

• BA / BS degree in the biological or health related sciences required, Master’s, PhD or PharmD preferred
• Minimum 3+ years of experience in Regulatory Affairs
• Minimum 7+ years of pharmaceutical, biotechnology or life science industry experience
• Knowledgeable of EMA and European guidance’s, regulations, drug development process, and industry-standard practices
• Possess strong written, oral communications
• Demonstrate proven interpersonal skills and experience working cross‑functionally throughout the organization
• Detail‑oriented, ability to work proactively, organize, prioritize, and delegate assigned projects
• Experience interacting with CROs e.g. CTAs, Clinical trial activations experience preferred
• Experience of EU / European health authority systems such as IRIS, CTIS is desirable
• Proficient user of standard MS Office suite (e.g., Word, Powerpoint, Excel), experience using electronic document management systems, and document review tools desirable

Summit does not accept referrals from employment businesses and / or employment agencies in respect of the vacancies posted on this site. All employment businesses / agencies are required to contact Summit’s human resources department to obtain prior written authorization before referring any candidates to Summit.