Global Regulatory Cmc Lead

vor 1 Tag

Basel, Schweiz Hobson Prior Vollzeit

Hobson Prior are collaborating with a brilliant pharma establishment who are currently looking for an individual to join their team on a permanent basis located in either Basel or Stockholm. Our client is focused on offering novel remedies that will transform the lives of those suffering from rare illnesses. Th opening position is for a Global regulatory CMC Lead.

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 handle answers to queries from the authorities to guarantee early approval both in a timely and efficient manner.
- Engage wit regulatory authorities on reg CMC concerns.
- You will evaluate data offered to assist with preparing dossiers.
- Review submitted manufacturing alterations for international impact and offer regulatory tactics that assist the change execution.
- You will represent the regulatory affairs CMC division on allocated cross-functional project teams.
- Author/gather CMC sectors of regulatory proposals which involves clinical trial and variations/supplements and registration proposal globally.
- Any other assigned duties.

**Key Skills**:

- A high attention to detail with the ability to resolve issues.
- Able to make good judgements.
- Communication skills both verbally and in writing.

**Requirements**:

- Educated to a degree level in a life science discipline though an advanced degree would be ideal.
- At least 7 years of experience in CMC regulatory affairs with ongoing responsibilities.
- Exhibited knowledge within international CMC regulatory.
- Familiarity with new product registrations.
- Capable of handling communications with health authorities.
- Know-how of international regulatory guidelines.
- Acquaintance with planning electronic proposals.
- Capable of serving as a representative for CMC regulatory proposals as a member of project teams.
- Fluency in the English language.
- Computer literacy in PowerPoint, Word, Excel, etc.
- Exhibits the company's core values: Care, Ambition, Urgency, Ownership and Partnership.

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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