Be an early applicantLess than 25 applicants

Company

BioSpace · 1 day ago

Associate Director of Regulatory Affairs

United States

Full-time

Remote

Director/Executive

$152K/yr - $186K/yr

10+ years exp

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Comp. & Benefits

H1B Sponsor Likely

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Responsibilities

Build intra- and inter-team relationships and collaborate in a global team environment at all levels of the organization to ensure management of regulatory strategy and activities in all applicable regulatory jurisdiction (e.g. EU, US, UK) for the global development of products through all stages of development and post approval. Participate in global product team meetings; provide regulatory support and guidance and manage day-to-day regulatory activities

Manage complex issues and coordinate multiple projects simultaneously in a time-sensitive fashion while practicing sound judgment as it relates to risk assessment (immediate and long term impact on program)

Create and follow procedures for regulatory execution and implementation of regulatory strategies while actively supporting program leads via the Clinical Study Teams (CSTs) to deliver on business objectives for assigned products/programs (e.g. clinical trial applications, marketing authorization applications, orphan drug designation applications, pediatric submissions, etc.). Create, collaborate and comply with disclosure and transparency policies for applicable jurisdictions

Collaborate with strategic operations and other functions (e.g. Clinical, Commercial, Medical Affairs, amongst others) to provide regional regulatory insight for futuristic planning and considerations for the program

Serve, as needed, as the point of contact with relevant Health Authorities and/or lead interactions with such authorities or other relevant external stakeholders

Review and interpret regulatory guidelines and create a communication plan to distribute relevant impact assessment. Creatively think outside the box on how to influence and shape the future of regulatory sciences as it relates to use and validation of unprecedented use of technology to develop drugs effectively for faster paths to patients.

Learn: Keep current with regulations and guidance documents; attend meetings, seminars, conferences on relevant topics; read journals, newsletters, scientific papers; research the answers to RA questions. Represent regulatory function and demonstrate respectful behavior, leadership, ethics and transparency.

Qualification

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Global Regulatory AffairsRegulatory SubmissionsRegulatory StrategyHealth Authority InteractionProject ManagementOrganizational Awareness

Required

A minimum of 10 years in the pharmaceutical industry with a minimum of 8 years in Global Regulatory Affairs, experience with major Health Authority (US FDA, Health Canada, UK MHRA and EMA) is mandatory

Minimum of 6 years experience with regulatory submissions (e.g. Investigational New Drug Applications(INDs), New Drug Applications (NDA/NDS/MAA), post marketing measures, Paediatric Investigation Plans (PIP)/(PSP) and Orphan Drug Designation (ODD), Breakthrough Designation (BTD), EU PRIME activities) are mandatory.

Strong understanding of regulatory strategy and implementation of operational activities.

Outstanding management, interpersonal, communication, negotiation, and problem-solving skills.

Demonstrated proficiency in organizational awareness, including experience working cross-functionally and on global teams.

Benefits

Bonuses

Equity compensation

Comprehensive benefits package

Company

BioSpace

BioSpace is the leading online community for industry news and careers for life science professionals.

Founded in 1988

San Francisco, California, USA

11-50 employees

http://www.biospace.com/

H1B Sponsorship

BioSpace has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2020 (2)