Company Description
The Bracken Group was established by seasoned industry professionals to provide life sciences consulting to pharma, biotech, and the companies that serve them. Our mission is to provide highly experienced consultative support for the development of products that are designed to improve life, in an ethical manner, underpinned with integrity and quality.
Job Description
The Regulatory Affairs Specialist will preferably have experience with pre-IND, IND and ideal NDA preparation and submissions for drug and/or biologics products or have just completed a course or degree in regulatory affairs The ability to interpret and apply regulations and guidelines to successfully support client products through innovative pathways with support from the senior consultant team.
Responsibilities include:
- Direct interaction with clients
- Integrate into client cross-functional project teams
- Prepare submission documents as part of INDs and NDAs and provide regulatory input
- Project Management of multifaceted projects
- Manage and support client regulatory affairs meetings
- Manage and support client regulatory affairs meetings with the FDA and other regulatory authorities
- Conduct research and regulatory intelligence and prepare summaries
- Be prepared “to roll-up their sleeves” and support the team in basic as well as complex aspects
Qualifications
Requirements:
- Preferably 1 - 3 years of regulatory experience or just completed a diploma or degree in regulatory affairs
- Previous exposure to therapeutic areas (e.g., oncology, pulmonary, auto immune, and infectious diseases)
- Preferably knowledge in IND and NDA (eCTD) Preparation
- Knowledge of device submissions would be ideal
- EMA experience ideal
- Demonstrate exceptional attention to detail
- Eager to learn and creatively problem solve with a positive, professional demeanor
- Ability to multitask and manage multiple priorities
- An attentive team member who takes pride in everything they deliver as a reflection of themselves
- Ability to work independently and with a virtual team
- Proven capability to communicate critical issues and proposed solutions to senior management levels with the ability to successfully manage stakeholders even in critical or sensitive situations
Additional information
All your information will be kept confidential according to EEO guidelines.
Additional Information
Benefits of Working with Bracken
- Remote always culture (has been a remote team since inception in 2016)
- Unlimited vacation policy
- Flat structure. Work directly with the leadership team.
- Free books program
- Exposure to wide range of other company’s teams, marketing playbooks, and internal operations
- $100 per month cell phone and equipment stipend
- Short term and long-term disability insurance
- Healthcare, dental and vision plan (company contributes 50%)
- 401(k)
- Sometimes you’ll be on video call with the CEO’s cat who likes to take up the whole screen
Bracken Marketing Core Values
We are looking for a high-energy, motivated individual who values:
- Analytical problem solving
- An always learning mindset
- Collaboration, team-focus
- Resilience
- Kindness
The Bracken Group was established by seasoned industry professionals to provide life sciences consulting to pharma, biotech, and the companies that serve them. Our mission is to provide highly experienced consultative support for the development of products that are designed to improve life, in an ethical manner, underpinned with integrity and quality.
The Regulatory Affairs Specialist will preferably have experience with pre-IND, IND and ideal NDA preparation and submissions for drug and/or biologics products or have just completed a course or degree in regulatory affairs The ability to interpret and apply regulations and guidelines to successfully support client products through innovative pathways with support from the senior consultant team.
Responsibilities include:
- Direct interaction with clients
- Integrate into client cross-functional project teams
- Prepare submission documents as part of INDs and NDAs and provide regulatory input
- Project Management of multifaceted projects
- Manage and support client regulatory affairs meetings
- Manage and support client regulatory affairs meetings with the FDA and other regulatory authorities
- Conduct research and regulatory intelligence and prepare summaries
- Be prepared “to roll-up their sleeves” and support the team in basic as well as complex aspects
Requirements:
- Preferably 1 - 3 years of regulatory experience or just completed a diploma or degree in regulatory affairs
- Previous exposure to therapeutic areas (e.g., oncology, pulmonary, auto immune, and infectious diseases)
- Preferably knowledge in IND and NDA (eCTD) Preparation
- Knowledge of device submissions would be ideal
- EMA experience ideal
- Demonstrate exceptional attention to detail
- Eager to learn and creatively problem solve with a positive, professional demeanor
- Ability to multitask and manage multiple priorities
- An attentive team member who takes pride in everything they deliver as a reflection of themselves
- Ability to work independently and with a virtual team
- Proven capability to communicate critical issues and proposed solutions to senior management levels with the ability to successfully manage stakeholders even in critical or sensitive situations
Additional information
All your information will be kept confidential according to EEO guidelines.
Benefits of Working with Bracken
- Remote always culture (has been a remote team since inception in 2016)
- Unlimited vacation policy
- Flat structure. Work directly with the leadership team.
- Free books program
- Exposure to wide range of other company’s teams, marketing playbooks, and internal operations
- $100 per month cell phone and equipment stipend
- Short term and long-term disability insurance
- Healthcare, dental and vision plan (company contributes 50%)
- 401(k)
- Sometimes you’ll be on video call with the CEO’s cat who likes to take up the whole screen
Bracken Marketing Core Values
We are looking for a high-energy, motivated individual who values:
- Analytical problem solving
- An always learning mindset
- Collaboration, team-focus
- Resilience
- Kindness
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