Regulatory Affairs Manager Antiseptics

Mölnlycke Health Care

Regulatory Affairs Manager Antiseptics

Mölnlycke is a world-leading medical solutions company. We design and supply solutions to enhance performance at every point of care – from the hospital to the home proven it every day. We specialize in: • Wound management: including dressings with Safetac® such as Mepitel® and Mepilex® • Preventing pressure ulcers: with Mepilex® Border used prophylactically and devices to help turn and re-position patients • Surgical solutions: including Mölnlycke trays, HiBi® antiseptics and Biogel® surgical gloves Mölnlycke was founded in 1849. Nowadays our solutions are available in around 100 countries; we’re the number one global provider of advanced wound care and single-use surgical products; and we’re Europe’s largest provider of customised trays. Our headquarters are in Gothenburg, Sweden and we have about 7,800 employees around the world. For more information, please visit: www.molnlycke.com

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Regulatory Affairs Manager Antiseptics

We are currently recruiting a Regulatory Affairs Manager to manage the Antiseptics portfolio and act as key speaking partner and subject matter expert for regulatory affairs within the Antiseptics business area. You will manage the pre-market process applicable for the products in the Antiseptics portfolio and execute regulatory strategies in accordance with the business unit strategy. In this role you will develop and provide regulatory strategy for primarily Europe, but also the Middle East and Asia Pacific, to implement actions according to corporate and business area objectives. You will be part of the Global Regulatory Affairs team and the position is based at Mölnlycke HQ in Gothenburg, Sweden or at our Oldham site in the UK.

Key Accountabilities

  • Create and execute regulatory plans for our Antiseptics assortment in accordance with business strategy
  • Provide regulatory input into new product development and lifecycle management initiatives
  • Prepare and submit eCTD applications (MAA, variations, renewals, etc.)
  • Liaise with regulatory authorities regarding license submissions and compliance activities
  • Interact with all stakeholders (R&D, Commercial, Marketing, QA, etc.) providing direction/strategy from a regulatory perspective
  • Write and maintain procedures and work instructions relating to regulatory activities
  • Participate in regulatory inspections (GMP/GDP/GPVP)
  • Ensure compliance with regulatory standards for Europe, Asia Pacific and Emerging Markets
  • Participate in project teams for pre- and post-market activities
  • Work with local regulatory functions to support registration activities in USA, APAC and MEA
  • Oversee external consultants, manage relationships and implement appropriate agreements
  • Meet with contract manufacturers to develop working relationships and support license compliance
  • Maintain regulatory database for tracking submission activity and status

Qualifications and Experience

  • University degree in medicine, pharmacy, engineering or another relevant scientific discipline or equivalent through combined experience and education
  • Minimum of five (5) years’ experience within European pharmaceutical Regulatory Affairs and a GMP environment
  • Documented experience of eCTD software and publishing
  • Computer proficiency with standard software programs
  • Knowledge of biocidal products is desired but not essential
  • Knowledge of USA regulatory framework is desirable but not essential
  • Fluent in English and used to work in a multicultural environment

The person we are looking for demonstrates specialist knowledge as well as project management, problem-solving and decision-making skills. You have a methodical and analytical approach and the ability to understand and analyze complex matters and make rational judgments and clear priorities. You are a strong communicator, and you have the ability to work independently as well as a strong team player with the interpersonal skills to drive change.

Why Mölnlycke?

This is an exciting opportunity to join Mölnlycke, a world-leading medical products and solutions company that equips healthcare professionals to achieve the best patient, clinical and economic outcomes. This is a chance to be part of an international company with friendly people and a chance to work for a fast-growing organization that empowers its people and supports them to develop their careers.

To apply

This recruitment is handled by H&P Search & Interim. Please contact us for more information. Alternatively, you can apply directly by uploading your resume below.

We look forward to your application!

H&P Search & Interim

Karin Tomin, karin.tomin@hpsearch.se, tel 0726-013 619

Catharina Bergold, catharina.bergold@hpsearch.se, tel 0702-179879