Associate Director, Regulatory Affairs Cmc
vor 1 Tag
Proclinical are proud to announce our exclusive partnership with Ultragenyx Pharmaceuticals in support of their ongoing European expansion.
Ultragenyx are a US based biotech committed to the development of innovative therapies for patients with serious rare and ultra-rare genetic diseases. Their unique approach has led to the successful development of multiple first-ever disease treatments at speeds faster than industry average.
As a result of the rapid expansion of their Biologic, mRNA and Gene-Therapy portfolios we are seeking an Associate Director, Regulatory Affairs CMC who will play a key role in continued development and eventual commercialisation of their products. This role is on a permanent basis with flexibility to work on a hybrid basis in Basel.
**Responsibilities**:
- Head the development of regulatory strategies and collaboration with global Health Authorities; offer strategic input and regulatory guidance to the project teams on clinical programs and life cycle management of marketed products.
- Organise the task of drafting responses to CMC correlated questions from FDA/global health authorities per established process.
- Assess proposed manufacturing changes for global impact to ongoing and existing dossiers and provide a regulatory assessment and a submission strategy for optimal implementation of changes.
- Co-operate and deliver support to Regulatory International for appointed program activities.
- Support the arrangement and direction of Agency meetings, involving planning and organisation of briefing packages.
- Support the organisation in maintaining a work atmosphere focused on quality and that fosters learning, open communication, collaboration, integration, and teamwork.
**Skills & Requirements**:
- Educated to a BA/BS degree level in life sciences in chemistry, molecular biology, or related is required, an advanced degree is preferable. RAC certification is desirable but not compulsory.
- At least 10 years of experience in Regulatory Affairs CMC in the pharmaceutical and/or biotechnology industry. Alternatively, 6 years pharmaceutical Regulatory CMC experience merged with at least 4+ years of pertinent pharmaceutical experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance or Quality Control).
Exhaustive understanding of relevant drug development regulations and guidelines is vital to support programs during development and commercial lifecycle. Demonstrated ability to successfully interact with regulatory authorities.
- Operating knowledge in the rare disease space and the ability to deal with matters of critical importance, offering regulatory advice and making reasoned decisions on regulatory problems for which there may not be clear/specific regulatory guidance is fortunate.
- Solid understanding of scientific principles and regulatory CMC requirements relevant to all stages of pharmaceutical drug development and manufacturing, process validation, analytical operations, compliance, and documentation supported by a strong quality mindset.
- Co-operative and team-oriented attitude to foster operative and constructive interactions across functions, project teams, regulatory agencies, and corporate partners, supported by exceptional people and organisational skills, involving the ability to prioritise and being flexible to changing priorities.
- Operative written and verbal communication skills combined with brilliant editing skills for technical documentation, in-depth attention to detail is a must. Strong capabilities with computer and standard software programs.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
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