Job Description

Associate Director, Regulatory Affairs ***Start as a US Liaison but grow into GRL or Therapeutic lead ***  Take projects from P2 to BLA *** Remote on EST

“With over 20 indications in their pipeline, there are lots of options if you favor a certain stage of development, but with the idea that all roads lead to you managing your own BLAs and/or moving into a GRL or Therapeutic Lead role.”

Location: This role can be remote if you are based in the EST zone

Our client is a medium-sized global Bio/Pharmaceutical company with a great development pipeline (20 NMEs) and an impressive number of recently approved products across their core therapeutic areas of Immunology and Neurosciences. They are well known for offering a dynamic and highly strategic regulatory working environment and they have a friendly culture where there are multiple career pathways/options available as a next step.

As a Regulatory Affairs Associate Director, you will be a Regulatory Strategy Lead for indications entering Phase 2 or 3, working cross-functionally with colleagues in the US and EU to inform, influence and ensure effective liaison across the organization to optimize regulatory strategies. There are also potential options to work in early development across the portfolio, to focus on projects in Phases 1/2 – but with over 20 indications still in development there are lots of alternatives, if you favor a certain stage.

In the short term, you will be given the opportunity to focus on your strengths and areas of high interest whilst also working on projects that fill in any gaps in your development experience. The idea/culture at this organization is to have their regulatory professionals experienced across the full development lifecycle so they can successfully navigate a BLA or move from a US liaison role to a GRL role.

In the longer term, as you gain more achievements, you will have the opportunity to be involved in new projects and regions and people management or operate as either the US or Global lead, or specialize in either early or late-stage development. The options here are varied and matched to your own ambitions and career goals.

The salary for this role is considered as strong and the benefits package is comprehensive and includes full medical and healthcare, high-level pension contribution from the employer, dental, a great holiday allowance, flexible working hours, and options to work from home.

For this position, you will need the ability to work well within a matrix environment, build team relationships and interface in a global team environment, and have experience of working on projects in either early or late-stage development.

Responsibilities

• Act as the primary regulatory representative on the assigned projects
• Define the company regulatory strategy for the biologic and small molecule programs, drawing from experience and creative, reasoned thinking to maximize opportunities and mitigate risks
• Oversee all regulatory matters and execute the strategy to ensure the organization complies with applicable regulations
• Lead regulatory initiatives across the portfolio
• Create and drive RA deliverables and ensure that phase-appropriate and compliant RA applications are submitted globally
• Author, review, and/or approve documentation, regulatory strategies, and RA global content for applicable submissions/programs
• Represent the company in communications and in meetings with health authorities, assessing the impact of new regulations, managing regulatory documents, etc. You will also be negotiating with regulatory authority personnel to expedite the review and approval of pending submissions while also responding to queries
• Show in-depth knowledge and understanding of applicable US regulations/guidelines for drug or biological products.

Experience required

• Candidates will need experience in aspects of clinical development (Pre-Clinical, IND, Phase 1, Phase 2, Phase 3) and be able to support NDA/BLAs, with the ability to participate in multiple project teams, develop strategies and lead/co-lead discussions with the applicable Health Authorities (FDA).

If you are interested in this position, in the first instance please contact Theo Moore at Theo@AdvTalent.com / 587.216.9302 or my colleague Ivan.Nash@AdvTalent  / 908.378.8980 to discuss the role and/or your application.