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Post Market Regulatory Affairs Director

2 months ago

Chester, Cheshire, United Kingdom Sinclair Full time

About the Role

Sinclair is seeking a highly skilled Regulatory Affairs Manager to lead our Post Market Regulatory Affairs Team. In this role, you will oversee product market approvals in line with global regulatory standards and internal policies. You will collaborate closely with our Injectables manufacturers, Business, and Commercial teams to achieve key performance indicators and strategic goals.

Key Responsibilities

  • Lead the Corporate Post Market Regulatory Affairs Team, providing expert knowledge and guidance on regulatory legislation and guidelines for devices in global territories.
  • Mentor, coach, and develop team members to ensure they have the necessary skills and knowledge to perform their roles effectively.
  • Define performance goals and targets, conduct performance reviews, and hold individual career development conversations with team members to manage toward achieving team goals.
  • Identify and participate in appropriate training events and activities to ensure personal development within the field of post market regulatory affairs.
  • Develop and implement post market regulatory strategies to achieve further approvals for company products in global territories.
  • Communicate changes in regulations or requirements to management and work with in-country distributors or contractors to determine regulatory requirements for product registrations in those regions.
  • Ensure all authorisations/registrations related to established products are maintained and monitor pending submissions to ensure timely approvals.
  • Interact with regulatory consultants, regulatory and trade associates, and other third-party service providers to ensure their provision of requested activities to agreed timescales.
  • Provide relevant regulatory advice and guidance to assist other Sinclair personnel in the performance of their roles and responsibilities.
  • Review and approve product artworks and partner marketing material according to applicable regulations.
  • Ensure maintenance of all submission documents, shared drive folders, and databases in an accurate, complete, and timely manner to ensure prompt and accurate access to company regulatory information.
  • Input into budgeting review specifically with reference to global post market regulatory requirements.
  • Ensure purchase orders for global activities are raised as necessary and manage invoices for relevant projects.
  • Maintain monthly business reports as necessary.
  • Liaise with and assist the Corporate Vigilance Team with respect to vigilance requirements of product dossiers and post marketing activities where necessary.
  • Organise consular and translation services.
  • Facilitate agreement between Sinclair Pharmaceuticals Ltd Legal and in-market partners regarding PoA/LoA expectations.
  • Provide technical/regulatory input to Change Control Post Market Regulatory Assessments (RoW) and associated RCN/RFRI.
  • Ensure preparation and maintenance of local market Site/Plant Master Files (SMF/PMF) for Sinclair affiliate sites.
  • Provide Post Market Regulatory support to the global EU MDR Strategy to ensure post market activities are planned and executed as part of the implementation processes.

Requirements

  • University Degree in a scientific field.
  • Minimum 6 years' experience in Post Market Regulatory Affairs Management within a Medical Device or Aesthetics organisation.
  • Working knowledge of the Medical Device Regulation.
  • Knowledge of other regulatory legislation and guidelines, e.g., US, Canadian regulations, APAC, LATAM, MEA, CEE/EU.
  • Excellent attention to detail when reviewing and preparing documentation.
  • Organised, target-oriented, flexible, good time management skills.
  • Strong written and oral communication skills.
  • Fluency in written and spoken English.

Desirable

  • Proven people leader in a regulated environment supporting regulatory teams.
  • Specific knowledge in dermatology/aesthetics.
  • Experience working with drug/device combination products.
  • Performance-driven critical thinker with strong business acumen.
  • Ability to coordinate and prioritise multiple demanding tasks in a fast-paced environment.
  • Ability to work effectively in a team environment and build strong working relationships.

Key Skills

  • Personal responsibility.
  • Communication, impact, and influence.
  • Analytical and critical thinking capacity.
  • Time management, organisation, and planning.

Benefits

  • 25 days annual leave (plus bank holidays).
  • Bonus based on performance.
  • Free parking.
  • Opportunities for development and progression.
  • Company pension scheme.
  • Private medical insurance.
  • Healthcare Cash plan.
  • Health Screening.
  • Employee Assistance Programme.
  • Store discounts.
  • Tech and Cycle Scheme.
  • Discounted dining card.
  • Cycle to work scheme.
  • Green car scheme.
  • Holiday buy and sell.
  • Life Assurance scheme.