Regulatory Affairs Manager

Cencora

United Kingdom (Remote)

#R246678

Position summary

aintenance of existing products in the market. Responsible for ensuring legal compliance with the Alvita product range throughout its entire lifecycle, protecting our consumers and the brand's reputation.

Provide regulatory leadership to the Alliance Healthcare business on fulfilling legislative obligations and work with other cross-functional colleagues in the development and introduction of new processes and procedures within the Alvita Quality Management System.

This role will work collaboratively with colleagues across other key functions within Alliance Heathcare, both within the divisional team and local teams. This includes brand, commercial, sourcing ,supply chain and quality teams.

JOB CONTEXT

Alvita is Alliance Healthcare's own brand of patient care products, with over 650 products covering medical devices, cosmetics and biocides, currently sold in in 7 markets across Europe., with plans for further potential expansion. The Alvita range is supplied by over 51 suppliers located in 20 different countries.

The Alvita brand has been identified as a key company growth initiative, with a 5-year plan targeting 2.5 x growth of current revenue and doubling of profit. Over half of the targeted growth will come from New Product Development (NPD) launches. This role will be integral in delivering the NPD required to support the growth plan.

This role requires an individual who can be flexible, deliver at a pace, deal with ambiguity, and demonstrate a strong capability for developing productive internal and external cross-functional working relationships.

This role will need to develop strong and productive working relationships with key suppliers' regulatory and supply teams to facilitate the successful development of the Alvita range and the delivery of the NPD Plans on budget.

KEY RESPONSIBILITIES

  • Responsible for managing the regulatory tasks in launching multiple NPD projects in accordance with the budget and 5 year growth plan.

  • Support the Alvita European Brand Manager and Central Sourcing Team in assessing potential new products, supporting the evaluation of claims and product attributes of products offered by alternative suppliers.

  • Responsible for coordinating and managing artwork origination on projects, coordinating the artwork process with suppliers, legal manufacturers, design agencies, and colleagues across the seven markets to deliver new products on the plan.

  • Work collaboratively with the Central and local Teams to ensure the documentation on Alvita SharePoint is complete for all projects and organized to facilitate easy access to local in-market teams when asked to respond to requests for information from national Competent Authorities.

  • Responsible for becoming the subject matter expert on medical devices within the business and ensuring plans are in place to maintain compliance with the requirements of Medical Devices Regulation (EU) 2017/745 and the in Vitro Diagnostic Medical Device Regulation (EU) 2017/746, in the context of our obligations as an own brand.

  • Demonstrate an innovative approach to obtaining market intelligence from suppliers and/or other sources, which can support the brand and local commercial teams in identifying new product opportunities and developing long-term NPD plans.

  • Support the European Head of Regulatory Affairs and Pharmacovigilance in specific projects related to Alvita, including assessing the launch in new territories or the development of new processes necessary to deliver compliance with European and local legislation.

  • Support the European Head of Pharmacovigilance and the European Head of Quality in developing the vigilance process for Alvita products.

  • Collaborate with the Central Quality Team and other colleagues to develop appropriate central and local procedures and working practices within the Alvita Quality Management System.

  • Work collaboratively and build strong working relationships with central and local cross-functional teams to manage the assessment of new products and maintenance of existing products in the Alvita range.

  • Take a vital role in the Monthly Operational NPD Meetings with the European Business units.

What your background should look like

SPECIFIC SKILLS

  • Self-motivated, dynamic and tenacious individual with the ability and desire to work proactively, with limited supervision.

  • Ability to prioritise and organise workload and react to the changing needs of the business.

  • Proven track record of working effectively under pressure.

  • Proven ability to communicate clearly and logically, both orally and in written form.

  • Ability to persuade and influence internally and externally at a range of levels.

  • Good working knowledge of Excel.

EXPERIENCE

  • Experience working within the Medical Device and or Cosmetics Industry.

  • Knowledge of appropriate European regulations and guidelines within the Medical Devices and Cosmetics Industry.

What Cencora offers

All team members globally are provided with basic life insurance, personal accident insurance, business travel accident insurance, and EAP resources at no cost. Additional country-specific benefits such as healthcare, sick leave, death and disability, retirement, as well as perks and allowances may be provided. Details of programs vary by location.

Schedule

Full time

Affiliated Companies

Affiliated Companies: Alliance Healthcare Management Services Limited

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status or membership in any other class protected by federal, state or local law.

The company's continued success depends on the full and effective utilization of qualified individuals. Therefore, harassment is prohibited and all matters related to recruiting, training, compensation, benefits, promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment, please call 888.692.2272 or email [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned