Senior Regulatory Affairs Associate OTC

Job Title: Senior Regulatory Affairs Associate OTC

Location: Berkshire

Duration: ASAP - 12 month contract

The Client: Global Pharma Company

Benefits: Competitive Salary and benefits available - Full details available on application

The Role:

Manage and execute Regulatory activities across EMEA within OTC brand categories to meet Commercial/Regulatory requirements for the client
Contribute to develop OTC regulatory strategies and formulate registration plans.
Co-ordinate R&D actions with EMEA medical activities
Manage EMEA Regulatory functions as these relate to OTC, to provide a proactive, cost effective, efficient and competent regulatory affairs service dedicated to meeting the needs of its European and World-wide customers.
To be a proactive and credible business partner to Regional and in-market business stakeholders for the projects under responsibilities.
To contribute to regulatory strategies to guide Global New Product Development and contribute to Global Regulatory process development for OTC products.

Full details available on application

The Candidate:

Life Science Degree or equivalent qualification.

Minimum Experience Required:

5 years of progressive experience in European Regulatory Affairs with International experience preferred.
2 years of management experience in pharmaceutical, biotechnological or Clinical Research Organisation (CRO) industries, preferred.
Demonstrate excellent leadership and good communication skills.
Demonstrate strong organisational skills, including the ability to prioritise workload.
Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific and manufacturing.
Strong flexibility and adaptability to a changing environment
Strong sensitivity for multi-cultural/multi-National environments.
Well organised, detail-oriented, effective in written and oral communication.
5-8 years of progressive experience in European Regulatory Affairs with International experience preferred.
OTC Experience would be preferred - 2 years of management experience in pharmaceutical, biotechnological or Clinical Research Organisation (CRO) industries, preferred.
Demonstrate excellent leadership and good communication skills.
Demonstrate strong organisational skills, including the ability to prioritise workload.
Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific and manufacturing.
Strong flexibility and adaptability to a changing environment
Strong sensitivity for multi-cultural/multi-National environments.
Well organised, detail-oriented, effective in written and oral communication.

Application Details:

If your skillset is relevant for this role, please click to apply on the link below. However, if this role doesn't suit your current skill-set, please call Alex on for further advice.

Candidates must provide confirmation that they have valid and existing permission to live and work in the UK.

If you do not hear back from us within 5 working days of your application for this role, it means that on this occasion you have not been shortlisted for the next stage of the recruitment process.

About Apex: Apex International are an honest, knowledgeable and niche agency who recruit for the pharmaceutical, biotech and CRO sectors in the UK and EU. We specialise in the areas of: Medical Information, Medical Affairs, Pharmacovigilance, Drug Safety, Regulatory Affairs, Clinical Research, QA & QC, Clinical Data Management, Health Economics, Marketing and Pharmacy (Pharmacists, Pharmacy Technicians and Dispensers). For a confidential and professional chat about your job requirements with an agency who are expert in the fields they recruit for, and for the chance to register for free and receive weekly job updates, please call on or email

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