Head of Regulatory Affairs

Ashford Gray; Toronto; On-site; EUR 80,000 - 90,000; Full time

Job summary

A pharmaceutical group in Toronto is looking for a Regulatory Affairs Manager to develop regulatory strategies and manage a dedicated team. The ideal candidate will have 8-10 years of experience in regulatory affairs and strong knowledge of global regulatory frameworks. This is an opportunity to work in a fast-paced and dynamic environment, overseeing compliance for a growing portfolio of products.

Qualifications

• 8-10 years previous experience in regulatory affairs.
• Knowledge of medical devices is highly desirable.
• Ability to work under pressure and within time constraints.

Responsibilities

• Develop and implement regulatory strategies for product development.
• Manage a team to ensure compliance with regulations.
• Integrate new portfolio acquisitions in multiple markets.
• Lead projects to identify and resolve dossier gaps.
• Collaborate with Quality and Commercial/Marketing teams.

Skills

Strong knowledge of global regulatory frameworks

Attention to detail

Organisational skills

Resilience and adaptability

Job description

This is a great opportunity to join a pharmaceutical group which is enjoying significant growth both in Ireland/UK and internationally. The group of companies are proud of its expanding business which includes market leading brands across OTC and Prescription medicines. This role will suit someone who is fast paced and looking to work in an environment that is anything but mundane!

The company works with a trusted network of global partners to identify and introduce clinically proven products

Responsibilities

- Develop and implement regulatory strategies to support product development and lifecycle management

- Manage a team of Regulatory Affairs Officers to ensure the Company’s products comply with all relevant regulations and standards

- Efficiently integrate all new portfolio acquisitions in multiple markets

- Lead projects on identifying any gaps in dossiers and devising plan to resolve these gaps.

- Lead meetings with Regulatory Authorities

- Lead regulatory aspects of internationalising products and applying for reclassification of products

- Monitor and interpret regulatory trends and changes relevant to the industry and pro-actively keep the Company appraised of these.

- Collaborate cross functionally with Quality and Commercial/Marketing teams to achieve Company objectives

Knowledge & Experience:

· Highly resilient and adaptable, able to work under pressure and within time constraints

· Drives results on a timely basis and sees things through to conclusion

· Strong knowledge of global regulatory frameworks

· Knowledge of MRP, DCP, CP

· Knowledge of medical devices highly desirable

· Excellent attention to detail and organisational skills

· Capable of working on own initiative and taking responsibility for course of action

Flexible and fast paced

8-10 years previous experience will be needed

Salary: €80,000.00-€90,000.00 per year