www.ofertapune.net Regulatory Affairs Specialist | PunaIme

Regulatory Affairs Specialist





Data e publikimit


Data e perfundimit


Lloji i orarit

Full Time


Industri Farmaceutike

Regulatory Affairs Specialist

The Position

Roche is a company with a 125-year history and our ongoing success is based on our strong focus on delivering meaningful value for our customers and society, and we will need to evolve our offering and approach in order to do so. Health care is changing exponentially due to radical innovation in technology, increased openness to change, increasing patient empowerment, multiple sources of medical information, and pressure on public spending.

This is an external staff position. Your employer will be a third-party supplier, in service for Roche.

Main Responsibilities:

  • Ensure that all Product Licenses in Kosovo are fully up-to-date and compliant at all times.
  • Responsible for ensuring that all regulatory documentation is effectively managed and that all regulatory submissions and approvals are accurately documented within relevant systems and databases.
  • Ensure that progress of applications and changes to registered details are communicated to local and global stakeholders, as appropriate, with minimum delay.
  • Interact and negotiate with local HAs and internal stakeholders to build and cultivate trusted partnerships and achieve successful regulatory outcomes.
  • Take active participation in shaping the policy environment.
  • Develop and manage effective working relationship with the regulators in Kosovo, Roche International Regulatory and other key customers.
  • Maintain a level of knowledge of local and international regulatory legislation and awareness of changes within the regulatory environment.
  • Ensure the timely communication on changes in local (Kosovo) regulations to Roche Global and to the local stakeholders in accordance with Roche requirements.
  • As assigned, gather and disseminate regulatory intelligence within the Affiliate.
  • Ensure regulatory filings are aligned with commercial and supply needs to assure business continuity and provide Regulatory Affairs input into relevant cross-functional Affiliate business strategies.
  • Develop innovative, risk-based regulatory strategies and work plans for assigned products or business areas within the Affiliate to accelerate access of medicines to patients.
  • Builds strong relationships and ensures good collaboration and communication between LTO and other affiliate, regional and global functions.
  • Support regulatory audit / inspection-readiness for the Affiliate, including leading or participating in internal/external regulatory audits.
  • Ensure assigned Affiliate activities comply with Roche global standards and local regulations.

Who you are

  • University education – pharmacist.
  • Experience in the pharmaceutical industry and in a regulatory environment.
  • Excellent understanding of the pharmaceutical industry, drug development environment.
  • Extensive knowledge of relevant regulations and ability to evaluate the impact of those regulations within the external and internal environment.
  • Commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadline.
  • Strong verbal and written communication skills.
  • Analytical and problem solving skills.
  • High degree of proficiency in Albanian and English language.
  • Ability to work as part of a team.
  • Excellent listening and decision-making skills.
  • Well-organized, detail oriented professional and ability to prioritize and make decisions.
  • Highly self-motivated; able to lead initiatives with authority.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Roche is an Equal Opportunity Employer.


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