Head of Labelling
Vor 7 Tagen
Hobson Prior are seeking for a Head of Labelling to join a fantastic biopharmaceutical establishment on a permanent basis located in Basel. For more information, please get in touch now
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 the company's executive labelling committee (ELC) and be accountable for follow-up on ELC decisions involving labelling.
- Guide a team of international labelling leads.
- Participate in the development and upkeep of regulatory affairs working practices and processes.
- Encourage collaborations with project/program teams to guarantee crucial proposal milestones are met.
- You will set functional objectives which contribute to the sectors vision and long-range preparation.
- Guarantee that product labelling reflects a complete and precise description of the risks and benefits of the company's products based on accessible data.
- Offer oversight of labelling operations work which involves artwork and mock-up production and updates.
- Any other assigned duties.
**Key Skills**:
- Outcome driven and team focused outlook with the ability to impact results.
- An organised individual with the ability to manage time efficiently as well as various current projects simultaneously.
- Capable of being novel with analysing and resolving issues while under mínimal supervision.
- A high attention to detail.
- Communication skills both verbally and in writing.
- Able to handle tactical and transactional duties concurrently within a small team setting.
**Requirements**:
- Educated to a degree level in a life science discipline with 10 years of experience, at least 8 of which were within regulatory affairs in a labelling position and at least 5 of which were professionally managing people.
- Familiarity with regulatory labelling for prescriptions and engaging with regulatory agencies which involves USA FDA on labelling problems.
- Previous involvement working with numerous pharmaceutical products.
- Acquaintance with guiding and handling updates to prescribing information.
- Former involvement in guiding projects as well as cross-functional teams.
- Knowledge of FDA guidelines and direction on content and format of product labelling.
- Know-how of advertising and promotion guidelines.
- Capable of comprehending guidelines to promotional and non-promotional materials.
- Knowledge of the drug development procedure, with focus on IND and NDA procedures.
- Computer literacy in MS Office, etc.
- Fluency in the English language with knowledge in a other language would be advantageous.
- Adhere to the company's core values.
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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