Associate Director, Global Regulatory Cmc

vor 3 Wochen

Baar, Schweiz Biogen Vollzeit

Job Description**
About This Role**

This global role is responsible for development and implementation of a consistent regulatory CMC compliance framework for Global Regulatory CMC commercial products. This will include working with a broad range of stakeholders to set and monitor internal standards and policies relating to compliance while staying abreast of relevant regulatory and industry trends, consulting and educating.
**What You’ll Do**
- Design, implement and monitor a consistent regulatory compliance framework for Global Regulatory CMC commercial products with key stakeholder input
- Identify and support team members with escalation of any potential critical compliance risks to Global RegCMC leadership
- Liaise across the company with stakeholders on compliance topics which require Global Regulatory CMC input and co-ordinate Global Regulatory CMC input into those topics and processes
- Act as a business process owner for Global Regulatory CMC various commercial product compliance related activities supporting the system designs. These activities include change controls, deviations/exceptions, product defects and recalls, falsification/diversion, agency regulatory commitments, annual product reviews and dossier compliance activities
- Remain up-to-date on the global regulatory compliance landscape, best practices and developments in the industry in liaison with Regulatory Intelligence and Policy colleagues
- Collaborate closely with Regulatory Intelligence and Policy on preparation for and implementation of new/revised regulations into Regulatory CMC systems and business processes (e.g. expanded IDMP implementation, KASA etc.)
- Facilitate the set up, monitoring and continuous improvement for the transition of Regulatory CMC activities to other functions when these are identified

Qualifications**
Who You Are**
- You are a strategic and results focused person, able to overcome obstacles and achieve key outcomes as well as to challenge the status quo in a constructive manner. You are driven by the opportunity to come in and set up a new function within our Global Regulatory CMC and to create a real impact in the overall organization.

**Required Skills**:

- At least 7+ years relevant experience in the pharmaceutical industry or a regulatory authority CMC review capacity, with at least 5+ years of experience in Regulatory CMC and preferably 2 years professional experience in pharmaceutical manufacturing, analytical development, and quality assurance/control or related technical field.
- Ability to work both independently with mínimal direction and within project teams, committees, etc. to attain group goals.
- Demonstrate excellent leadership and emotional intelligence, along with verbal and written remote working communication skills.
- Solid Project Management skills.
- Proven ability to obtain results in a global, cross-site matrix environment. Ability to manage projects across global locations/time zones. Proven ability to create strong working relationships in a global setting with many different cultures.
- Proven ability to mentor, develop, and retain regulatory CMC professionals, including ability to motivate staff to perform at their top level.
- BS University degree in basic Life Sciences, Engineering, Biotechnology, or relevant Pharmaceutical Science; Graduate degree highly preferred.

Additional Information
This role will ensure that Biogen regulatory obligations as part of lifecycle management of commercial products are complying with the most current regulatory standards and that compliance risks are appropriately identified and mitigated. This role reports directly to Global RegCMC Commercial Products Head and supports Biogen commercial products portfolio registered globally.

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