Regulatory Manager

Vor 6 Tagen

Fribourg, Schweiz Hobson Prior Vollzeit

Hobson Prior are currently looking for a Regulatory Manager to join a fantastic pharmaceutical industry on a permanent basis located in Zurich. This role is also open to those who attain an EU citizenship who are happy to relocate to Zurich. Our client is focused on discovering the right treatment solutions for patients.

Please note that to be considered for this role you must have the right to work in this location.

**Key Responsibilities**:

- For this role, you will be responsible for creating strong ground-breaking and operative regulatory tactics for international rollouts with the focus on China for all company portfolio.
- As a Regulatory Manager, you will be successful in procuring registrations that meet the company's objectives and expectations.
- Regulatory documents and tracking information are inserted and maintained in the global regulatory systems in accordance with internal procedures.
- For China, you produce strategies in association with the local regulatory affairs team based in China, while having a strong knowledge of regulatory landscape and suitable interpretation of guidelines, directives etc.
- Participating early with global brand and development teams to discuss specific considerations related to regulatory frameworks in China and accelerate the approval of the company portfolio.
- You will be collaborating with the local RA team to guarantee early engagement with local Health Authorities and stakeholders to accomplish the affiliated strategies.
- Act as the SME for China and relate with Brand and Development teams to offer requirements in the relevant core market(s) and support initiation of critical activities.
- As the Regulatory Manager, you will support the compilation, submission and maintenance of CTAs for clinical development programs (where applicable) and NDA, in alignment with GRA objectives.
- Analyse and warrant that the design and conduct of clinical development programs and individual studies are suitable to produce data supportive of registration in China.
- Any other assigned duties.

**Key Skills**:

- Able to multitask and handle various and fluctuating urgencies with the ability to prioritise and delegate.
- Robust interpersonal skills and excellent communication.
- You are detail-oriented with solid organisational skills and the ability to distribute operational objectives.
- Capable of maintaining a high level of discretion.
- Operate well both individually and in a team setting and network effectively and successfully with peers, management and third parties.
- You will implement an entrepreneurial way of thinking and spirit.
- Applies strategic thinking.

**Requirements**:

- For this role, you will have obtained a university degree, ideally in a pharmaceutical or health related field.
- At least 6 - 8 years of experience in regulatory affairs in the pharmaceutical industry (mainly dealing with prescription drugs).
- Exhibited first-hand experience of working in a fast-paced team environment.
- Capable of speaking and writing in the English Language.
- Preferably, you are also capable of speaking and writing in Chinese, however, this is not essential to the role.
- Prior experience offering tactical regulatory advice for the global development of products through all stages of development including pre-approval and marketed compounds for international markets, specifically for China.
- Able to handle the flexibility that comes with the role as you may occasionally work unusual hours due to the international nature of operations.
- Contented in collaborating in multidisciplinary teams across time zones and perceptive to cultural differences and linguistic challenges.
- Understand the Business Impact & Strategy.
- Recognise major stakeholders and predict their needs.
- Strong understanding of drug development and regulatory policy; outstanding scientific and business judgment.
- Pat know-how in functioning in a matrix organisation and multidisciplinary team within the pharmaceutical industry.
- You will have gained familiarity with the global regulatory environment.
- Firm grasp of where to seek and how to interpret regulatory information.
- Exceptional computer skills, counting proficiency with MS Office (including Word and PowerPoint).
- Effective display of GRA compliance with the company and external standards.
- Understanding of the local health authority regulations, guidance, and regulatory requirements.
- Experience in clinical development.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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