Regulatory Consultant

3 weeks ago

Maidenhead, United Kingdom Proclinical Full time

Proclinical are recruiting a Regulatory Consultant for a biotech organisation. This role is on a contract basis with the ability to work remotely from anywhere in the UK.

**Responsibilities**:

- Guide the regulatory evaluation of commercial/medical resources working in collaboration with commercial and medical teams and external regulatory associates.
- Offer regulatory due diligence examinations in collaboration with business development when needed.
- Handle relationships with distribution associates and regulatory affairs consultancies to guarantee business goals are met.
- To assist with successful product launches in central eastern Europe and middle east, you will offer country-specific methodical regulatory guidance to country managers.
- Other duties may be assigned to this role.

**Key Skills and Requirements**:

- Educated to a degree level in a scientific or similar field.
- At least 5 years of experience of country-specific European Regulatory needs for novel products in late-stage development as well as post approval.
- Familiarity with middle east product registration would be beneficial.
- Preferably an amalgamated mix of large company best practices and smaller company adaptability and acquaintance.
- Expertise on European regulatory affairs and affiliated needs.
- Past involvement in interfacing with national competent authorities within Europe.
- Capable and willing to work within a high-visibility, fast-paced setting.
- A flexible individual with a high attention to detail.
- Able to resolve issues with solid analytical capabilities.
- Works well in a team as well as able to take own initiative.
- Fluency in the English language.
- Communication skills both verbally and in writing.
- A result oriented individual with the ability to meet deadlines and work well while under pressure.
- A motivated individual with the ability to plan and prioritise workload.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

LI-PD1

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