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Regulatory Affairs CMC Manager

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Regulatory Affairs CMC Manager
Job Description:

Regulatory Affairs CMC Manager

Job Purpose:

Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute
to global regulatory submissions and strategies.

Major Activities:

- Author high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global
regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines and
e-publishing requirements throughout project lifecycle.

- Prepare CMC responses to health authority questions during development, registration and product lifecycle.

- Identify the required documentation for global submissions and negotiate the delivery of approved technical source
documents in accordance with project timelines.

- Identify content, quality and/or timeliness issues with source documents, or any other potential authoring issues
that may impact submission quality or timelines, as early as possible.

- Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for
new technical trends.

- Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the
critical issues and lessons learned.

- Establish and maintain sound working relationships with partners and customers.

- Assume activities in support of the general department such as DRAGON support, annual and product renewal writing,
coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry
activities (specialized department functions).

Ideal Background:

- Education (minimum/desirable):

Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent

- Desirable:

Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.


- Fluent English required (oral and written)

- Good skills in site (local) language desired (oral)

Experience/Professional requirement:

- Regulatory experience preferred, and/or experience in drug/biopharmaceuticals

- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug
development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.

- Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.

- Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on
multiple projects under pressure of time and workload.

- Effective planning, organizational and interpersonal skills.

- Reasonable approach to risk assessment.

- Excellent written/spoken communication and negotiation skills.

- Computer literacy.

Allegis Group Limited operates as an Employment Business and Employment Agency as set out in the Conduct of Employment
Agencies and Employment Businesses Regulations 2003. It is a company within the Allegis Group network of companies
(collectively referred to as "Allegis Group"). Aerotek, Aston Carter, EASi, TEKsystems, Stamford Consultants and The
Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis
Group Online Privacy Notice available at https://www.allegisgroup.com/en-gb/privacy-notices.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you,
and describes your rights and choices about this, please go to https://www.allegisgroup.com/en-gb/privacy-notices.

We are part of a global network of companies and as a result, the personal data you provide will be shared within
Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the
protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland
and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online
Privacy Notice at https://www.allegisgroup.com/en-gb/privacy-notices for details on how to contact us. To protect your
privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account
associated with your request, or identifying information such as your address or date of birth, before proceeding with
your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in
accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy

Required Skills:

CMC, GMP, GxP, Regulatory Affairs, Regulatory Compliance, Regulatory Documentation, eCTD, Regulatory Guidelines,

About Aerotek:

Aerotek is a leading provider of technical, professional and industrial recruiting and staffing services. We do not
provide engineering services directly but specialise in locating and placing qualified engineers with customers who are
seeking their skills. Aerotek is a division of Allegis Group Limited, a wholly owned subsidiary of Allegis Group Inc.,
the fourth largest staffing company in the world. Allegis Group Ltd is an Employment Business and Agency. Aerotek
operates a network of more than 150 non-franchised offices, employing 2,000 recruiters to identify, screen and select
top talent.

Contact Information:

Brendan Walsh


TEL : +41 61 202 90 67

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