Senior Regulatory Affairs Manager - Consumer Health
- Chemistree Solutions
- Hybrid working - 2 days home-based with 3 days in the office - office location Slough or Paddington
- Negotiable competitive salary, car allowance, bonus and additional benefits package
- Start date
- 14 Feb 2023
- Closing date
- 7 Apr 2023
- Regulatory Affairs
- Full Time
- Contract Type
- Experience Level
Senior Regulatory Affairs Manager - Consumer Health. Exciting new opportunity in Berkshire working for an established healthcare company.
Role: Senior Regulatory Affairs Manager Health
Products: Consumer Health
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
This 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.
- 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).
- Monitoring, collecting, interpreting, and applying all relevant legislation, regulatory issues & trends and regulatory guidelines in the UK and keep the UK business up to date on national regulatory trends, risks and opportunities. Providing advice to the business on regulatory issues as necessary and assist in developing of strategies and plans of action to address them.
- 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.
- Educated to Degree level or equivalent business experience, preferably with a science background.
- OTC or Pharmaceutical regulatory affairs experience is essential.
- Line management experience of 1 or more direct reports is essential.
- Graduate calibre, with regulatory and product safety experience.
- Thorough understanding of the current regulations, laws and industry requirements.
- Exceptional ability to manage workload and identify priority tasks to meet tight deadlines.
- Strong influencing / communication expertise.
- Ability to build good relationships and challenge constructively and confidently.
- Ability to consolidate large volumes of complex information, interpret & construct straightforward plans.
- Naturally inquisitive.
- Confident and capable of operating at all levels and able to resolve conflict situations.
- Competent with PC tools and information systems.
- Ability to challenge the status quo and propose improvement.
- Able to apply appropriate problem-solving techniques to evaluate and resolve operational issues.
- Ability to motivate and coach people within a results-oriented culture, where personal responsibility/initiative, teamwork, and mutual respect are key.
If you are suitable for this position, please send a copy of your CV. Alternatively call the recruitment team at Chemistree Solutions Ltd. Chemistree is a pharmaceutical and healthcare recruitment specialist.
Chemistree Solutions Ltd are Healthcare Recruitment Specialists - we provide expert resourcing and recruitment services across sales, marketing, medical, clinical and commercial support functions and offer permanent, contract and interim solutions.
Established in 2006. We provide:
Extensive recruitment experience – structured to support your business at local, regional and global level, providing an Account Director as a single point of contact alongside a trusted recruitment team.
Flexible and tailored service – with the ability to evaluate, adapt and change in order to deliver a bespoke service and meet the needs of both customers and candidates
High quality candidate selection – drives our expertise for resourcing quality using a targeted robust screening process. We pride ourselves on providing an efficient service, supplying a short list of qualified candidates who are motivated and well briefed.
Exceptional results – we are leaders in healthcare recruitment. Our outstanding track record of performance is supported by industry leading case studies, performance metrics and testimonials
“Successful recruitment lies at the heart of business success”
- 0115 937 3515
3 Holme Farm Close
Willoughby on the Wolds
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