Regulatory and Quality Manager SE

Provides the leadership for all regulatory activities in the SE zone. Acts as Responsible Person to allow import, export and distribute food and cosmetics in EU (requirement for a Monaco-based company. Manages product registrations, notifications and submissions to Regulatory Authorities (primarily France, Spain and Italy). Leads response to regulatory issues raised by regional and national regulatory bodies, working with internal and external legal counsel.

 

Key Responsibilities/Duties

 

Regulatory Affairs

• Registrations/Listings/Submissions – Manage product and site licenses, registrations and notifications for all markets in zone, including France, Italy and Spain. Collate and prepare product data for submission to Regulatory Authorities.

• Response to regulatory changes/issues - Lead Nelsons response to regulatory issues in the zone, liaising with Regulatory Authorities and regulatory/legal consultants as required. Keep up-to-date on upcoming changes to regulations and impact on Nelsons.

• Artwork/Labeling/Advertising – Develop, review, and approve artwork/labeling to ensure compliance to local regulations for dietary supplements and cosmetics. Review and approve marketing material, brand websites and social media content for technical accuracy and regulatory compliance.

• New product development/Innovation – Provide guidance on regulatory opportunities and barriers to help develop new products and claims aligned to the brand innovation strategy. Work collaboratively with colleagues to assess compliance risks and propose appropriate solutions.

• Educational Material - Help develop product educational material for Sales, Marketing, Customer Services and pharmacists that detail product benefits.

• Training - Provide training of staff on the regulatory environment and internal procedures relevant to the categories of our products (food, food supplements, homeopathics, cosmetics).

• Technical support for Pharmacists: Act as a primary point of contact for pharmacists/customers on technical product questions.

• Establish key business relationships – Participate with relevant Industry Associations and liaise with regulatory/legal consultants as required.

Quality

• Quality Management System - Develop local regulatory and quality policies and key SOP’s to meet local needs while also aligned with corporate policies (i.e. managing distributors, consumer complaints, artwork approval, training, quality audits, change control). Maintains ISO 9001 certification in France.

• Training - Train staff on key policies and procedures defined by the Quality Management System.

• Product Complaints/Inquiries – Support the Customer Service Department to respond to product complaints, including those involving adverse events (AE’s).

Ensure Customer Services capture the details on QPulse and liaise with UK Quality team when product investigations are required.

• Third Parties - Assist with initial assessment of third parties and ensures that quality audits take place as required (i.e. DSL Distribution Centre). Ensure Quality and Technical Agreements are in place with key third parties.

 

Qualification & Experience

• Science degree, pharmacy preferable.

• Significant experience of working in a Regulatory role with experience of food, food supplements and/or homeopathics.

• Understanding of product claims allowed for food supplements in EU and substantiation required – strongly desirable.

• Experience in working with Regulatory Authorities on product registrations, submissions and/or notifications.

• Experience working in a commercial and marketing environment - strongly desirable.

• Knowledge of Quality Management Systems.

 

Skills and Abilities

• Verbal and written fluency in French and English. Italian and Spanish is beneficial but not essential.

• Assertive with good influencing skills to build a culture of compliance and quality across the SE organisation.

• Ability to work independently to ensure the SE leadership team prioritises consumer safety and product quality.

• Able to find pragmatic solutions to regulatory issues.

• Ability to drive improvement and simplify existing working practices.

• Professional, confident, bright, self motivated.

• Excellent written and oral communication skills, and high attention to details.

• Able to work under pressure and adhere to deadlines.

• Enthusiastic approach to compliance by helping and educating colleagues.

 

Behaviours

• Supports commercial targets while maintaining focus of the leadership team on consumer safety and regulatory compliance.

• Assertive with the ability to influence the AMS leadership team.

• Pragmatic and able to work under pressure.

• Highly collaborative approach and able to work in a matrix organisation.

• Self-starter who takes initiative to resolve issues proactively.

• Passionate for natural health products.