Advanced Search


Start New Search:

immuno oncology
rare disease
gene therapy
program leader
site work
strategy consultant
competitive intelligence
global health
drug development
home based
regulatory affairs
senior consultant
associate director

Regulatory Strategy

Share Job
Suggest Revision
Opus RegulatoryCambridge, MA
  • Opus is committed, in accordance with applicable law, to a policy of nondiscrimination and equal opportunity for all employees and qualified applicants.
  • It will not discriminate on the basis of race, color, religious creed, national origin, ancestry, sex, marital status, sexual orientation, age, disability, or as a disabled Veteran, or any other basis protected by law.
  • While Management is responsible for the development of plans, programs, and controls to ensure that our policy is carried out, we expect all employees to provide individual and collective support for equal employment Opportunity at Opus Regulatory.
  • Opus Regulatory will provide reasonable accommodations, in accordance with the regulations of the Americans with Disabilities Act, and State law.
  • Opus Regulatory is committed to offering a comprehensive and competitive total rewards package to recruit and retain talented professionals.
  • Our benefits program offers a broad array of plans to support our workforce physically, financially, and personally.
  • Health & Wellness
  • 401k retirement plan
  • Short-term and long-term disability
  • Quality of Life
  • Paid personal days
  • Most Regulatory Consultant positions offer significant home-based arrangements
  • This summary is an overview of benefits to prospective employees.
  • More extensive information is provided to new employees upon hire.
  • Paid time off, paid holidays and paid personal days are offered to full time employees.
  • The Regulatory Affairs Principal Strategy Consultant is primarily responsible for the daily management of regulatory requirements for one or more drug products, designing and implementing submission strategy, and developing and maintaining relationships with key client staff and regulatory bodies.
  • Act as a key regulatory affairs expert within a client regulatory team, providing expertise on regulatory strategy, process, filing, best practices, etc.
  • in conjunction with client leadership.
  • Create and maintain primary and associated patient labeling, EU Product Information and labeling documents.
  • Ensure the quality and consistency of labeling documents, contributing to the continuous improvement of the client labeling process.
  • Lead or facilitate labeling approval meetings with relevant stakeholders (e.g., Regulatory, Legal, Marketing, Safety, Clinical) and advise teams on strategy, agency regulations, and guidance affecting labeling.
  • Provide support and guidance to regulatory teams on RA requirements for one or more drug products.
  • Maintain advanced knowledge of changing regulatory requirements and advise teams as appropriate.
  • Represent the client regulatory affairs team in other client meetings or workstreams; provide support for ancillary projects.
  • Perform other duties as assigned.
  • Position Types: Full or part-time; salary or hourly
  • Minimum experience: 6+ years pharmaceutical regulatory affairs experience
  • Minimum education: Bachelor’s degree (advanced degree in a science discipline preferred)
  • Extensive regulatory affairs knowledge and familiarity with RA concepts, procedures, practices, methods, and industry standards.
  • Substantial project management skill, with a demonstrated ability in planning, implementing, and executing tasks to meet RA goals.
  • Regulatory submission knowledge, including eCTD and NDA/IND requirements.
  • Steadfast attention to detail; ability to identify and communicate methods for improving existing processes
  • Ability to generate and employ original ideas to address simple and complex problems.
  • Ability to work in an ever-changing pharmaceutical environment.
  • Knowledge of regulatory affairs teams and ability to recognize when leadership is needed.
  • Ability to work collaboratively and direct the work of others toward common goals.
  • Ability to work in an ever-changing pharmaceutical environment and adapt to resource and knowledge gaps in client RA teams
  • Opus Regulatory - Today
  • Get job updates from Opus Regulatory
  • Let employers find you
  • Let Employers Find You

Similar jobs:

  • All Jobs
  • Active
Associate Director, Regulatory Strategy
Planet PharmaBoston, MA
Planet Pharma’s early stage, rare disease focused biopharma client is searching for an Associate Director, Regulatory Strategy to join their growing Regulatory Affairs team.
Associate Director, Regulatory Strategy - Early Pipeline
Vertex Pharmaceuticals, IncBoston, MA
Comprehensive understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology
Senior Consultant, Regulatory Affairs
Halloran Consulting GroupBoston, MA
Experience in oncology, Immuno-oncology, and/or cell/gene therapy
$150 - $200 Full-time
Senior Director, Global Regulatory Affairs Strategy
Vertex PharmaceuticalsBoston, MA
Education and Experience: Bachelor's degree in Biology, Chemistry, or other related discipline Typically requires 12 years of relevant pharmaceutical or biotech industry experience within regulatory affairs and 5 years of supervisory/management experience, or the equivalent combination of education and experience Company Information Vertex is a global biotechnology company that invests in scientific innovation.
VP, Regulatory Affairs
Theseus PharmaceuticalsCambridge, MA
Reporting to the Chief Medical Officer, the Vice President and Head of Regulatory Affairs will develop, lead and drive the execution of the Theseus's regulatory strategy from pre-IND through regulatory approval to launch, commercialization and product lifecycle management.
How do Good Interviewers Prepare for Interviews?

Just like candidates take the time to research you and your company, you should take the time to prepare for the interview. Preparing for the interview doesn't just reflect well on your employer brand and create a better candidate experience. Preparation also helps prevent bad hiring decisions. Bad hiring decisions are usually a result of poor execution during the hiring process. However, going into an interview fully prepared and ready to evaluate candidates will help avoid bad hires. So, here are 6 interview preparation tips for employers.

Director, CMC Regulatory Affairs
Foghorn TherapeuticsCambridge, MA
Foghorn Therapeutics is seeking an experienced and effective leader for the role of Associate Director (AD)/Director, CMC Regulatory Affairs.
Director Strategy - Vault Regulatory
Veeva SystemsBoston, MA
Committed to innovation, product excellence, and customer success, our customers range from the world’s largest pharmaceutical companies to emerging biotechs.
$200 - $250 Full-time
Associate Director, Regulatory Affairs
Visterra, IncWaltham, MA
Having achieved a mastery of the fundamentals of regulatory affairs, the Associate Director will have the key role of integrating technical knowledge into their creative strategy to guide Sr. Leaders to achieve major company goals.
Associate Director Global Regulatory Affairs CMC - Hybrid
TakedaBoston, MA
8+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
How to Respond to a Recruiter Through Email? (Tips & Examples)

Rather than wading through an endless list of open roles, wouldn’t it be nice if relevant job opportunities come to you?

Associate Director Global Regulatory Affairs CMC - Hybrid
Takeda PharmaceuticalLexington, MA
8+ years pharmaceutical Regulatory CMC experience including experience as an RA CMC product lead, or equivalent industry experience (e.g., Pharmaceutical Development, Analytical Development, Production, Quality Assurance).
Director, Global Regulatory Affairs Strategy
SanofiCambridge, MA
Experience working in electronic document management systems, e.g. Veeva vault
Associate Director, Global Regulatory Affairs Development Strategy
Alexion PharmaceuticalsBoston, MA
As a leading employer in our industry, Alexion offers a highly competitive package of base and incentive compensation as well as a comprehensive benefits program designed to support the health, wellness and financial security of our employees and their families.
Vice President, Regulatory Affairs
Dynavax Technologies CorporationCambridge, MA
Provide guidance to and manage the regulatory team across regulatory specialties including regulatory CMC, regulatory advertising and promotional review, regulatory clinical support, regulatory operations and regulatory compliance.
Hiring Taking Too Long?

We all know one of the biggest downfalls of a successful recruiting and hiring process is the amount of time it takes to hire someone. The time it takes to hire is sometimes completely out of line with applicant's expectations, creating a huge gap between candidates and businesses. Meanwhile, most recruiters and hiring managers don't even notice that they're taking too long. They have been fighting the symptoms of a too-long-hiring process without addressing the problem at the root. Here, we will expose some of those symptoms and offer solutions to help shorten your hiring process.

Director, Global Regulatory Affairs Strategy
Sanofi GroupCambridge, MA
+ Experience working in electronic document management systems, e.g. Veeva vault
Senior Associate, Life Sciences, Regulatory Affairs
KPMGBoston, MA
Strong understanding of Regulatory Affairs related data and documents as well as experience with Regulatory Information Management (RIM) or Document Management systems preferred
$125 - $150

Latest Blog Posts: to Avoid a Bad Hire"A new employee who doesn't meet the minimum performance, quality, and culture fit standards you set when you began sourcing and recruiting. Additionally, bad hires will immediately show signs of self-interest instead of an interest in their role and the company." Long Do Background Checks Take for Pre-EmploymentMany jobs require a background check. For some companies, this is a matter of company policy. In other jobs, such as finance, childcare, and security, the government often requires background checks. While there are varying levels of intensity, for most people, a background check is nothing to worry about. In fact, the biggest question is often how long does a background check take? Here’s what job seekers and applicants need to know about background checks before they apply to new jobs. Best Remote Jobs: Where & How to Find ThemThe Covid-19 pandemic hasn’t been easy on any of us, but if there’s one silver lining, it’s the fact that remote work has grown in popularity because of it. Companies that previously weren’t open to their employees working remotely were suddenly forced into allowing it. Since then, they've realized that much of their workforce is happier and more productive. Naturally, this has led to more remote job openings, which is great if you’re interested in this type of position. Read on to learn more about the best remote jobs and where to find them. to Write a Short BioFirst impressions can be tricky. When meeting someone in person, it’s likely you have an elevator speech. These short, practiced introductions can help you share more about who you are, what you do for work and other facts about you. While this works well in a live, in-person context, there are many cases where professionals “meet” someone via written form - like social media, a resume, or published work. In these cases, your bio works as your first impression. So, here’s a step-by-step guide on how to write a short bio. to Conduct a Performance Review (With Examples)In a world where the smallest mistake can cost your business tens of thousands in lost revenue, your talent is key to keeping your edge on the market and driving growth. However, managing a workforce of any size can be a challenge. Employees come with their own particular skill set, ambitions and flaws. So, it can be difficult to uncover their individual drivers. Not to mention the challenges brought on by the hybrid and remote working models where in-person interactions have become few and far between. to Recruit Passive CandidatesLearning to recruit passive candidates is a different ballgame than recruiting active ones. While an active candidate is someone who is currently looking for a new job, a passive candidate tends to be the opposite. Passive candidates are either already working or not looking to work. So, instead of these candidates coming to you, you'll have to find them and reach out to them first. to Make a Job Offer More CompetitiveMoney alone makes it hard to attract and retain top-notch candidates, especially when you are competing with larger businesses and corporations in your industry. So, instead of focusing on money, figure out how to make a job offer more competitive when you can't offer more money.