- South Central

2 months ago

Berkshire, United Kingdom Chemistree Full time

Package: Negotiable competitive basic salary, bonus, car allowance and additional benefits package

Location: Hybrid working - 2 days home-based with 3 days in the office - office location Slough or Paddington

Role Type: Regulatory Affairs, Regulatory Affairs Manager, Senior Regulatory Affairs Manager

is a great opportunity to join an established global healthcare company as a Senior Regulatory Affairs Manager. The role reports into the Region Regulatory Affairs Director for UK and Ireland. In this role you will work on the front line of UK regulations (and Irish regulations when required), driving the activities required to meet the Business needs and priorities, and ensuring product compliance with all local regulations and internal processes. You will engage with external stakeholders, with a holistic view, lead and influence regulatory changes. This role has leadership responsibility for 4 direct reports.

You will be a Regulatory Affairs Professional with a strong commercial awareness and broad spectrum of skill sets in strategic regulatory affairs across Consumer Health categories (OTC medicines, medical devices, food supplements and cosmetics). Ideally proven experience in product launches, life-cycle management, OTC switches, project management and people management.

Key Responsibilities:
Working collaboratively with the relevant Global and country teams to establish and implement the regulatory strategies within agreed timescales to bring competitive advantage to the Company brands.

Management of all regulatory and development projects relevant to the UK brands. Manage/oversee regulatory strategies and the preparation of regulatory documents targeted at the UK Market (and Irish market when required).

Interface with relevant government agencies, industry associations and key opinion leaders to assess the impact and implementation of required company projects with all regulations and industry policies that affect the ingredients, packaging, marketing, advertising, labelling and production of the Company products.

Participation to due diligence activities related to new products.

Active participation at industry association working groups.

Support UK Drug Safety Officer and relevant qualified employees to ensure compliance with pharmacovigilance and quality obligations.

Provide advice and training on regulatory matters and requirements to the local business and global stakeholders as required.

Prepare or oversee training materials and conduct training sessions on relevant regulatory topics.

Assist the organisation for internal and external audits; co-ordinate internal investigations on regulatory matters as required.

**Qualifications**: Educated to Degree level or equivalent business experience, preferably with a science background

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