Senior Manager Drug Regulatory Affairs

Senior Manager Drug Regulatory Affairs

Santhera Pharmaceuticals

Pratteln, Switzerland

Scope of Work

The Senior Manager Drug Regulatory Affairs reports to the Head Drug Regulatory Affairs who is based in Pratteln and will collaborate closely with other functions such as Clinical Operations, Clinical Sciences, Pharmacovigilance, Biostatistics, Preclinical or CMC, based in the HQ in Switzerland.

The role is responsible for leading some global regulatory activities, including operational and strategic activities in drug development, registration and post-marketing phases.

Responsibilities include, but are not limited to

• Provision of regulatory input and support to Post-Approval Regulatory procedures in EU and ROW (document quality and accuracy, coordination of input from other line functions, coordination of the submission process):
  • Variations;
  • PSUR;
  • MA Annual Re-assessment;
  • Scientific advice;
  • Preparation of meetings with HA;
  • Pediatric investigational Plan.
• Clinical Trial Authorisation applications and maintenance:
  • Preparation and submission for regulatory approval of clinical trial authorisation applications;
  • Maintenance of existing clinical trial authorisations: Preparation and submission of amendments and the notification of start of trial and end of trial as required;
  • Input in decision process regarding clinical trials conduct and strategy;
  • Supervises regulatory CRO counterpart as applicable;
  • Communication with Regulatory Authorities in relation to CTA topics;
  • Study Management Team membership: provides necessary regulatory guidance and support to the SMT Santhera Pharmaceuticals is a Swiss specialty pharmaceutical company focused on medical science and the development and commercialization of innovative pharmaceutical products for the treatment of rare neuromuscular diseases with high unmet medical need;
  • Support DS&PV for the preparation and submission of the DSUR.
• Critical review of documents:
  • Ensures the accuracy, scientific validity and optimal presentation of applicable regulatory documents (IB, Protocol, IMPD etc.).
• Regulatory Intelligence:
  • Identify appropriate guidance, regulations and sources for regulatory compliance.
• Document management:
  • Filing and archiving the regulatory documents according to SOPs;
  • Maintenance of electronic filing systems and internal regulatory archive.
• Other Regulatory activities, as applicable.

Required Background and Experience

• Mandatory previous experience in a pharmaceutical company or a CRO;
• Minimum bachelor’s degree in life science;
• Minimum 8 years of experience in a similar role in Regulatory Affairs;
• Experience in clinical trial applications;
• Knowledge of EU/US clinical trials guidelines & regulations;
• Previous experience in operating within complex matrix organizations;
• Fluency in English, both written and oral.

Required Competencies:

• Excellent communication, interpersonal and networking skills;
• Self-motivation, personal resilience, perseverance, energy and drive;
• Ability to work independently and collaboratively, as required, in a matrix organization;
• Excellent planning and organizing skills;
• Flexibility in adapting to changing priorities and deadlines;
• Capable of dealing with ambiguity, risk taking and decision making in a fast-paced entrepreneurial environment;
• Open minded, solution oriented.

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