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Senior Technical Regulatory Affairs Manager

Location: 

Basel, BS, CH

 

 

About Idorsia Pharmaceuticals Ltd
Headquartered near Basel, Switzerland – a European biotech hub – Idorsia has a highly experienced team of dedicated professionals, covering all disciplines from bench to bedside; QUVIVIQ™ (daridorexant), a different kind of insomnia treatment with the potential to revolutionize this mounting public health concern; strong partners to maximize the value of our portfolio; a promising in-house development pipeline; and a specialized drug discovery engine focused on small-molecule drugs that can change the treatment paradigm for many patients.

 

We are looking for a Senior Technical Regulatory Affairs Manager to join our team !

 

Job Responsibilities

 

    • Write, update, and keep track of the Module 2 (Quality Overall Summary) and the Module 3 (quality) of CTDs for global marketing applications,
    • Write, update, and keep track of the Quality part of the IMPD, IND (and other technical regulatory documents) for global clinical trials application,
    • Prepare Briefing Books and supportive documentation for Health Authority meetings (pre-IND, pre- NDA, End of Phase II, Scientific Advice meetings),
    • Write the answers to the quality questions raised by the Health Authorities following the submission of global Marketing /Clinical Trial Applications and technical variations,
    • Negotiate, plan, and coordinate with internal and external stakeholders (CMC and DRA project leaders, partners) strategies leading to regulatory submissions and clinical/commercial supplies,
    • Assess and communicate the regulatory impact and regulatory requirements of products changes,
    • Store regulatory documents and track versions within the relevant document management systems,
    • Keep track of global submissions, approvals and/or implementation acceptability dates,
    • Operational and strategical contribution to forms, guidelines, and procedures,
    • Organize reviews (CMC team, Management, DRA, management committee), assess the comments and consolidate technical documents for global regulatory submissions,
    • Ensure consistency between raw data and registration documents contents,
    • Prepare and track Pre and Post approval synopsis,
    • Store technical regulatory documents within the relevant document management systems using up- to-date dictionaries and meta-data.

 

Candidate's Requirements

 

    • University degree (Msc, PhD) in Pharmacy (Pharm D), Chemistry or biology, or alternative technical/science university degree,
    • Experience of at least 5 years in technical/CMC regulatory field or similar positions in the pharmaceutical industry,
    • Good organizational and communication skills,
    • Ability to proactively initiate and lead preparation of CMC documentation for filing activities,
    • Ability to manage multiple tasks with competing priorities,
    • Ability to manage complex projects,
    • Ability to communicate clearly and professionally both verbally and in writing,
    • Good MS Office, Veeva, DocuBridge skills,
    • Good spoken and excellent written English Knowledge of any other European language would be an advantage,
    • Knowledge of, and understanding of ICH guidelines (Quality), GMP requirements, Regulatory procedures (US-FDA, EU-CHMP, and others such as Health Canada, Swissmedic, Japanese PMDA, Chinese FDA),
    • Advance knowledge of drug substance and/or Drug Product development, manufacturing process, quality control, packaging activities and regulatory environment.

 

Work Location: Basel Area

Country: Switzerland

Business Area: Technical Regulatory Affairs

Schedule: Fulltime

Job Type: Permanent

 

 

At Idorsia, we harness the power of difference, authenticity, and inclusion to achieve business success.
We encourage all potential candidates with diverse backgrounds of race, color, religion, sexual orientation, gender identity, age, national origin, and disability to submit their job applications. All applicants will receive consideration.
We are committed to fostering respect, fairness, and equal opportunities for all job applicants and our employees.

Please be informed that if you are selected for this position, your employment will be subject to a pre-employment background screening process, of which you would be informed in greater detail in due course.

Idorsia Pharmaceuticals Ltd ("Idorsia") is committed to a fair and transparent application process. In order to avoid any conflict of interest in line with Idorsia Code of Business Conduct, which would undermine such a commitment, the applicants  must disclose any personal, financial, or other outside interests interfering with the interests of Idorsia. Further, the applicant is obliged to disclose any and all relationships with close or affiliated persons, who are employees of Idorsia or are collaborating with Idorsia in any other contractual relationship. 

Please note Idorsia operates a strictly controlled list of preferred recruitment partners. For those partners who have no valid, signed Master Service Agreement in place with Idorsia, all unsolicited resumes, CVs, anonymous profiles, or any other candidate details submitted through our website or to personal e-mail accounts of employees of Idorsia Pharmaceuticals (including any of its subsidiaries, affiliates, or related companies) are considered the property of Idorsia Pharmaceuticals and are not subject to payment of any form of introduction, placement or referral fees.

 

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