- Are you looking for a role to approve gene therapies for European & International markets?
- Do you have experience in biologics or cell & gene therapy programs?
- Have you worked on phase 3 programs through to approval and launch?
- Managing all aspects of submissions relevant to assigned projects and programs, in accordance with submission and regulatory requirements.
- Leading cross-functional groups across the organization in the development of relevant data to complete post-approval and developmental regulatory submissions.
- Defining contributions for submissions, communicate to functional contributors and tracking delivery according to agreed timelines.
- Managing activities to maintain regulatory filings including planning and preparing IND/CTA applications and amendments, annual reports, MAAs, BLA amendments, PBRERs, DSURs etc.
- Leading the development of briefing documents for formal regulatory meetings.
- Providing regulatory guidance to project teams.
- Anticipating regulatory obstacles and emerging issues, including changing regulations, throughout the product lifecycle and developing solutions with other members of regulatory and related teams.
- Initiating and contributing to local process improvements which impact various functional groups.
- Developing and maintaining cooperative relationships as the point of contact with partners and regulatory health authorities.
- Contributing to the development of EU/International regulatory submissions.
- Managing and continuously improving the development of regulatory processes to support compliance activities.
- Supporting the development of regulatory processes for submission planning and management.
- Developing and mentoring junior regulatory team members.
- Bachelor's in Life/Health Sciences required
- Ideally has an advanced degree in a scientific discipline and 6+ years of related experience (may also have a Bachelor's degree with significant related experience - generally 10+ years). Individual experience may vary based on skillset and expertise.
- Pharmaceutical or related environment with biologics experience desired.
- Working understanding of EU regulatory requirements pertaining to the submission of regulatory documents.
- Proven ability to coordinate submissions independently in a time intensive situation
- Demonstrated track record of supporting EU regulatory applications (e.g. Clinical Trial Applications, Marketing Authorization Applications, Pediatric Investigational Plans, and Scientific Advice).
- Experience of working directly with the EMA and EU/UK national regulatory agencies and leading agency meetings.
- Thorough knowledge of different regulatory pathways and market planning across key regions.
- Previous experience working with novel drug therapies and orphan products is desired but not essential.
- Familiarity with the drug development process.
- Previous experience with gene therapy is desirable.
- Good knowledge of regulatory history, policies, guidelines, standards, practices, requirements and precedents.
- Current understanding and knowledge of GxPs (GCPs, GLPs, GMPs) and ICH guidelines as well as FDA, international, and, if applicable, local regulations.
- Exemplary interpersonal communication and organizational skills.
- Proven ability to multi-task, manage competing priorities (i.e. working on two or more projects with overlapping timelines).
- 20% bonus
- Stock options
- This job description in no way states or implies that these are the only duties to be performed by the employee(s) incumbent in this position. Employee(s) will be required to follow any other job-related instructions and to perform any other job-related duties requested by any person authorised to give instructions or assignments.
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Director Regulatory Affairs - Nottingham, United Kingdom - Fraser Dove International
Description
Regulatory Affairs Director
Fraser Dove International is partnering exclusively with an innovative biotechnology organisation specialising in gene therapy. Operating globally, they are committed to challenging the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.
Our client is seeking a dynamic leader to provide strategic input and leadership to project teams in support of developmental and post-approval projects.
Discover more about our Regulatory Affairs Director opportunity; its objectives, duties/responsibilities and the skills, experience and competencies needed to succeed.
Your objectives:
As the Regulatory Affairs Director, you will be measured against the following objectives:
1) Responsibility for leading relevant submissions including CTA submissions, briefing documents for agency interactions, orphan drug applications, paediatric investigation plans and marketing authorization applications.
2) Serving as the primary interface with the EMA and other international Health Authorities for assigned projects.
3) Responsibility for recommending strategies for the earliest possible approvals of clinical trials and marketing authorization applications.
What you will do:
As the Regulatory Affairs Director, your duties and responsibilities will include:
What you will bring:
These are the skills and experience you will need to succeed as the Regulatory Affairs Director:
What you will get:
These are the perks and benefits that will complement your generous base salary:
Got what it takes?
To apply for the Regulatory Affairs Director, click the 'Apply' button below or contact the Executive Search Consultant – Katy Barber – on
Please Note:
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Fraser Dove International is a specialist executive search firm operating exclusively in the life science industry. Passionate about people, we take pride in helping exceptional life science organisations source the talent they need to design, manufacture and distribute life-changing drugs, treatments and devices which transform and save patient lives.
