Senior Re­gu­la­tory Affairs Officer

Company Description

Mundipharma is a global (ex-US) network of independent associated companies that research, develop and manufacture innovative pharmaceutical medicines and consumer healthcare products. We are an agile and fast-paced company seeking to increase access to health care through programmes and effective partnerships.

We are forward-looking and dedicated to bringing innovative treatments to many of the world’s most challenging conditions and diseases including: Pain Management & Supportive Care, Consumer Health, Anti-Infectives, Biosimilars, CNS, Diabetes, Oncology, Ophthalmology, Respiratory and transplantation immunity.

We make a difference to patient lives by delivering value to healthcare professionals in 120+ countries across Africa, Asia Pacific, Canada, Europe, Latin America, and the Middle East.

Our guiding principles, centred around Integrity and Patient-Centricity, are at the heart of everything we do. We encourage our people to think differently and our inclusive culture of continuous learning and collaboration make Mundipharma a great place to work.

For more information visit www.mundipharma.com.

Job description:

Accountable for the IAC regulatory affairs in responsible IAC/country.
Drive optimal regulatory outcomes and ensure governance on regulatory activities in responsible IAC/country.

Responsibilities

  • Ensure full regulatory compliance to all local and international regulations, codes and standards and company SOP.
  • Prioritize assignments and implement regulatory plan and co-ordinate multiple projects and activities accordance with company objectives.
  • Be responsible for regulatory submissions and responses to deficiency letters, and timely tracking status of the progress, including new product registration, line extensions, variations, renewal and manufacturing site certificate application and maintenance.
  • Management of regulatory strategy to minimize plan lag, impediments and impact of emerging threats
  • Monitor and assess impact of regulatory changes in prescription medicines, medical devices and listed medicines in four jurisdictions
  • Ensure the filing strategy are aligned with global strategy.
  • Monitor and assess impact of regulatory changes in prescription medicines, medical devices and listed medicines in four jurisdictions
  • Liaises with local competent authorities pertaining the regulatory-related issues associated with compliance and achieving the business plan.
  • Establish and implement plans to maintain a trusted relationship with local authorities through regular meeting and discussions.
  • Liaise with other functions and give regulatory support
  • Gather and share regulatory intelligence such as current developments in the medical and scientific communities which may impact products and business with stakeholders.
  • To provide necessary documents to third party service providers for the maintenance of our products in their company system/database. (apply to the IAC manage 3rd party)
  1. Ensure annual regulatory budgets are prepared and maintained
  2. Ensure maintenance of appropriate document management systems for all Regulatory documentation
  3. Ensure maintenance of relevant global regulatory databases
  4. Ensure effective liaison with third-party manufacturers and laboratories to ensure timely communication of regulatory requirements and availability of regulatory information
  5. Ensure the business needs of internal stakeholders are understood and their expectations are effectively managed

Required profile:

Key Skills

  • Thorough understanding and demonstrated ability to apply regulatory guidelines/regulations to successful dossier preparation, submission and maintenance.
  • Ability to develop strategies and solutions within the regulatory context within the scope of global requirements and available resources.
  • Strong initiation and organization skills
  • Outstanding written and oral communication and negotiation skills.
  • Knowledge, experience and track record of delivering successful regulatory outcomes for regulatory activities
  • Well technical skills in the local HA online submission system or equivalent system


Educational Qualifications

  • Bachelor degree or equivalent or higher, in Life Science

Relevant Experience

  • Candidates must have at least 3 years’ experience in regulatory affairs dealing with a wide variety of registration projects and issues.

Language Requirements

  • Fluent in English and local official language are required in writing, reading and speaking
  • Proficient in Microsoft Office applications.

What we offer:

Competitve Salary
Role development

Gem job

Mundipharma A/S
Publiceret: 20. august 2021

Arbejdssted

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