Global Regulatory Manager
We have a further role with one of our long-established clients in North America, supporting and coordinating BLA activities for the US, EU, Australia, Switzerland and Brazil.
The role involves Health authority queries, maintaining trackers for BLA related activities, archiving correspondence, setting up meetings for cross-functional team discussion and much more.
The duties of the role will include:
- Support the Regulatory team in the preparation of HA interactions (meeting preparation, rehearsals, execution, follow-up, minutes, etc.)
- Schedule meetings & rehearsals, coordinate/assist with the preparation of a slide deck, provide regulatory administrative information for these documents.
- Maintain tracking data for health authority meetings, PMRs/PMCs, and other key regulatory milestones and liaise cross-functionally to generate periodic internal milestone reports
- Provide operational support on strategic regulatory documents to help drive timely deliverables.
Additional responsibilities, in conjunction with regional and/or global regulatory leads, include:
- IND, BLA, and NDA maintenance submissions provided by the submission manager
- Provide administrative information for the Annual report regarding study status & outstanding regulatory business related to the General investigational plan
- Coordinating and driving rapid response team meetings to ensure quality and timely responses to health authority queries. This includes the preparation of responses to HA queries according to the rapid response process.
- Maintaining global submission plans and supporting those plans can be executed on time
- Coordinating and driving global regulatory subteam meetings to ensure high-quality meeting discussions & outputs
- Solid scientific background (BS, MS, PhD, PharmD, in life sciences, chemistry, pharmacy, medicine or veterinary).
- 1-3 years of pharmaceutical industry experience. Ideally 1 year in regulatory affairs or 2-3 years in a complementary functional area (e.g., clinical research)
- Working knowledge of regulatory procedures (US or other)
- Demonstrates a high level of self-motivation and professional commitment.
- Ability to rapidly adapt to different issues and projects at one time.
- Excellent communication skills.
- Comprehensive understanding of the pharmaceutical industry.
- Comfortable working in a fast-paced environment where speed is paramount.
- Willing to work as a topic expert, outside of a traditional functional environment, in a team unified around serving the assets.
- Ability to recognize, articulate, and accept calculated risks to make informed decisions.
- Willingness and ability to effectively work in a highly matrixed team environment.
- Develop an understanding of different TAs due to assignments to different projects.
- Increased understanding of the regulatory procedures (US, EU, others) and regulatory landscape.
- Increased exposure to global and multi-functional teams.
- Strong team player with the ability to seamlessly collaborate across functional and geographic boundaries to achieve the company’s goals.
- Strong attention to detail
- Thrives on seeking and incorporating constructive feedback.
- Communicates opinions, facts and thoughts with clarity, transparency, and honesty.
- Demonstrates ownership of results within (and beyond) area of responsibility.
- Sets clear and high expectations and holds self and others accountable for decisions and results achieved.
- Looks for opportunities for continuous improvement.
G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status, or race. We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.
G&L is committed to everyone having the right to work in an environment free from the threat of discrimination, intimidation, harassment, and abuse. All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity.
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