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Regulatory Affairs Manager

Position Title: Regulatory Affairs Manager

Number of Vacancies: 2

Start Date: ASAP (earliest November; latest 1 Jan)

End Date: 6 months (extension possible)

Job Description Summary:

This position is within the Regulatory Affairs team, focusing on the AsiaPac Regions, providing crucial regulatory support for Seqirus-manufactured products within the Asia Pacific markets. An exciting opportunity has arisen for a Regulatory Affairs Manager within our Global Regulatory Affairs group. This role is tailored for an experienced Regulatory professional and encompasses work on all Seqirus manufactured products across the Asia Pacific region.

The Regulatory Affairs Manager, Regions role is a strategic position within the Regional regulatory team, contributing to the vision and goals of Global Regulatory Affairs and Seqirus. In this capacity, the role provides regional strategic advice and support to Project/Product teams, Regulatory CMC & Compliance, and Regions Commercial Operations and Business Development teams.

This role interfaces with other functions in Regulatory Affairs (e.g., Regulatory CMC & Compliance, Regulatory Operations & Compliance) and collaborates across the organization, especially with Clinical, Commercial Operations, and Business Development. This collaborative approach ensures connectivity with key stakeholders and a focused regulatory strategy supporting country and regional business objectives or global R&D objectives.

The Regulatory Affairs Manager, Regions will lead and execute the regulatory strategy for one or more products, ensuring high-quality submissions, up-to-date and compliant dossiers, and fulfillment of regulatory commitments. In some cases, the role may have direct reports co-located on-site and will be responsible for planning, oversight of their reports’ work, and on-the-job training and coaching.

This role is pivotal in developing collaborative and respectful relationships with staff at National Human Medicines Regulatory Agencies within the region (e.g., CBER/FDA, EMA, TGA). Additionally, the Regulatory Affairs Manager, Regions will represent the company at external regulatory agency meetings relevant to their project or product portfolio. This multifaceted responsibility underscores the strategic importance of the role within the broader regulatory landscape.

Qualifications:

Tertiary qualified in biological science, allied medical discipline, or pharmacy, preferably with a Masters or PHD or complementary experience in the pharmaceutical/biotechnology industry.

Skills/Experience:

A minimum of 7 years’ experience in regulatory affairs in any of the above industries working within the Asia Pacific region.

Prior experience in negotiating with local Health Authorities and driving regulatory submissions, including marketing authorization applications, to approval.

Previous regulatory experience in vaccines.

Fluent in English (written and verbal).

Strong, positive, established relationships with local Health Authorities.

Flexibility and ability to work effectively within a global organization comprising a range of different functional areas and cultures.

Strong customer focus.

Commitment to achieving objectives in a complex matrix environment.

Highly developed organizational skills, including planning and time management.

Problem-solving and analytical skills supported by good attention to detail.

Knowledge of device requirements would be a distinct advantage.

Team Size: 6 people

Flexibility: 1-3 days/week at the office; balance work from home.

Hours: 38/week (including some early morning or late evening calls) – occasional OT – flexible.

Overtime Rates: N/A – Daily rate

Potential to Extend: Yes. Likely.


Consultant: Nicole Consterdine, 0477 811 564

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