Regulatory Affairs Partner

4 weeks ago

Canada PharmaGroww Full time

About PharmaGroww

PharmaGroww is a leading global pharmaceutical organization dedicated to enhancing the quality of life for patients by providing and advancing specialty, hospital, and rare disease medications.

Our goal is to be the preferred partner for the commercialization of specialty, hospital, and rare disease medicines across various regions.

With a robust Centre of Excellence and a well-established global distribution and commercialization partner network, we are well-equipped to support our operations worldwide.

Role Overview

As PharmaGroww continues to solidify its status as the partner of choice for specialty, hospital, and rare disease medicines, we are excited to present an opportunity for a Regulatory Affairs Specialist.

Key Responsibilities

  1. Lead integration initiatives following mergers and acquisitions, taking charge of developing a streamlined process for integration.
  2. Generate regulatory intelligence necessary for pre-integration assessments and support Unit Heads during due diligence activities.
  3. Project manage integration efforts as part of a broader project team.
  4. Assist the Regional Manager in reviewing applications submitted by team members, ensuring high standards of evaluation and fostering the development of junior staff.
  5. Formulate strategies for complex regulatory submissions and engage in discussions with health authorities to establish a regulatory approach.
  6. Independently manage intricate regulatory submissions for the designated regional portfolio, focusing on timely approvals and ensuring supply continuity.
  7. Act as the process owner for complex regulatory procedures, seeking opportunities for process enhancement and simplification.
  8. Maintain oversight of regulatory updates for relevant regional authorities, facilitating cross-functional discussions and contributing to compliance with legislation.
  9. Represent the Manager in cross-functional meetings and authorize change control/artworks in their absence.
  10. Mentor junior team members on regulatory standards and assist in onboarding new hires.

Qualifications

• Graduate/Post-Graduate in any scientific discipline, preferably in life sciences or pharmacy.

• Extensive experience in regulatory affairs, particularly in lifecycle maintenance within a pharmaceutical context in UK/IE/EU markets.

• Strong understanding and practical experience with CTD, especially in writing and reviewing modules 2-3.

• Commercial awareness and insight into cross-functional dependencies.

• Familiarity with regional regulatory guidelines, CTD, ICH, and eCTD.

• Excellent project management and communication capabilities.

Our Culture

At PharmaGroww, we empower our employees to take initiative and embrace challenges, fostering both personal and organizational growth in a dynamic environment.

We celebrate diversity and are united by a shared commitment to improving patients' lives. We advocate for gender equality and actively promote women in senior positions.

We offer flexible working arrangements and a competitive salary and benefits package.

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