Quality Recruiting. Established Experts.
Vice President, Regulatory Affairs
Reference Number: 3810
Location: MA
Our client is a pharmaceutical development company. They have asked us to assist them in their search for a Vice President, Regulatory Affairs.
Major tasks and responsibilities will include:
- Develops and manages regulatory team.
- Drives regulatory process.
- Provides strategic regulatory leadership for all drug development projects and activities needed to secure approval.
- Leads coordination, preparation, and timely submission of all regulatory documents.
- Ensures timely filing and approval of new products.
- Oversees all Health Authority interactions, acting as primary point of contact. Leads all interactions, presentations, and negotiations.
- Participates on Medical-Legal Review Team.
- Interprets and articulates all FDA (and other regulatory body) communications, expectations, and decisions to internal and external stakeholders.
- Develops and implements solution based issue resolution strategies.
- Advises senior management of the potential impact of the changing regulatory environment.
- Strategically partners with the Vice President of Pharmacovigilance, and collaborates on FDA reporting.
- Supports post-marketing activities for commercial products, including review and approval of commercial labeling and advertising/promotional materials.
- Communicates and collaborates effectively across all departments and functions as regulatory subject matter expert.
- Maintains and creates relevant SOPs, Work Instructions, and other necessary guidance.
We seek candidates with the following qualifications:
- Bachelor’s degree in related field required. Advanced degree highly preferred.
- Must have 15+ years of pharmaceutical/biotech industry experience in regulatory affairs.
- Must have 5+ years of demonstrated success in a regulatory team leadership role, and proven management by influence.
- Requires BLA filing experience.
- Must have proven negotiation skills, direct experience with the FDA and international agencies, and knowledge of regulations and regulatory process in all global markets.
- Requires solid understanding of dossier requirements NDA, MAA, IND, IMPD, and CTA.
- Prior experience with biologics preferred.
- Requires proven excellence in operational strategy.
- Must be able to interpret, communicate, and present regulatory information in a succinct manner.
If interested, please email your resume as a Word attachment to us, reference 3810. No calls or faxes, please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.
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I enjoyed working with the staff at Fairway Consulting Group because they were professional, thorough, efficient and courteous in all communications.
- Senior Clinical Research Associate with a growing drug discovery and development company
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An area where they deserve tremendous praise is the area of negotiation of a fair package for all parties concerned.
- Director BioOncology Business Unit Operations, Leading Biotechnology Company
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The process was also made a lot easier with the small number of touch points at Fairway Consulting Group, where I worked with two consultants for the entire process and never had to explain my story to different people.
- Associate Manager Market Planning, Leading Biotechnology Company
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I am eternally grateful to Fairway Consulting Group. They are a class-act, and I wish them every success in the future.
- Director BioOncology Business Unit Operations, Leading Biotechnology Company
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I’ve worked with John Wiener and his staff for almost ten years and they’ve helped me secure two attractive positions with leading pharmaceutical companies during this time.
- Director New Product Commercialization, Major Global Pharmaceutical Company
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...thank you for all of your insights and coaching during my placement process... I'm delighted to be joining such a wonderful team.
- Manager Field Analysis, Major Global Pharmaceutical Company
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I have worked and dealt with a number of recruiting companies, but I have to say this has best my best interaction ever.
- Medical Director Imaging, Major Global Diagnostic Imaging Company
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Christopher is highly professional, energetic and efficient. He knows the pharmaceutical industry and was great at understanding my needs...
- Manager Outcomes Research, Major Global Pharmaceutical Company
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Dan… Now that I interacted with several head hunters, I think it is easy for me to say you are the best. You are sincere in finding a perfect match rather than making numbers and you do a very good job selling the truth about the position to the candidate and prepare the candidate for the interview. So keep doing what you do, you are very good at it.
- Director Drug Product Technology
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Jan is a true partner in the talent acquisition business. She is genuinely interested in making certain her clients are positioned to ensure long-term success for both parties. As a candidate, in preparation for the interview process, Jan was quickly able to provide me information about the position, the company, their culture, and key leadership profiles, ensuring I could best represent myself and critical skills and experiences that I brought to the table. Jan made sure all of my questions were immediately answered with quick and responsive communication. After accepting the position, Jan and I remain in contact today and she is always available to provide continued support and employment advice. She now provides me with recruiting assistance for my department and continues to remain true to form in assisting in the process on the employer’s side, while identifying the best talent for our needs.
- Senior Director Clinical Operations, Major Global Pharmaceutical Company
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Dear Jan, I cannot thank you enough for all the help and support you gave throughout the selection process, and most recently the hiring and relocation process with [name of company]. I have enjoyed working with you and am very grateful to you. I am extremely excited to start next week!
- Director Strategic Start Up & Patient Recruitment, Major Global Pharmaceutical Company
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Just wanted to take a quick moment to say thank you for all of your insights and coaching during my placement process at Novartis. I’m delighted to be joining such a wonderful team.
- Manager Field Analysis, Major Global Pharmaceutical Company
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Dan, I want to thank you for the work you have done with me for this position. It has been a great pleasure working with you. I have worked and dealt with a number of recruiting companies, but I have to say this has best my best interaction ever. And this is independent of the happy conclusion that should happen shortly with the signature of the offer letter. If someone needs an excellent professional in your field, your name will be at the top of my list.
- Medical Director Imaging, Major Global Diagnostic Imaging Company
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Dear Jan, I cannot thank you enough for all the help and support you gave throughout the selection process, and most recently the hiring and relocation process with [name of company]. I have enjoyed working with you and am very grateful to you. I am extremely excited to start next week!
- Director Strategic Start Up & Patient Recruitment, Major Global Pharmaceutical Company
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I enjoyed working with the staff at Fairway Consulting Group because they were professional, thorough, efficient and courteous in all communications. They listened to what I was looking for in my next career move and contacted me once they found something that fit my description. I would highly recommend using Fairway Consulting Group to any of my colleagues.
- Senior Clinical Research Associate, a Growing Drug Discovery and Development Company
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Jan was a true asset in helping me make my latest career transition. Her industry connections, sound guidance, and dogged determination proved invaluable for exploring/pursuing job opportunities. She proved an ally even after placement in navigating a particularly challenging situation during organizational realignment
- Director, Clinical Planning & Resource Management, Major Global Pharmaceutical Company
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Jan recruited me to my current position and always conducted herself in the most professional manner. She was a pleasure to work with through a time of transition. I highly recommend Jan.
- Medical Director, Drug Safety, Major Global Pharmaceutical Company
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Jan Platnick recruited me and helped place me at Genzyme Corporation. Jan is an excellent professional recruiter. She has an optimistic attitude and the tenacity required to succeed in her role. I am very pleased with the way Jan handled my placement and would recommend her unequivocally to anyone seeking to fill open professional positions.
- Director-MTS Technical Project Management, Leading Biotech Company
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I really enjoyed working with Jan, she is professional, focused and results orientated. I highly recommend her for the industry knowledge she has and the high level of personalized customer care she provides.
- VP Pharmacovigilance, CRO
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I wanted to thank you for initial contact and support through the selections process with AbbVie. I greatly appreciated you championing me and submitting me for consideration. I am very excited to start my new job!
- Director Strategic Start Up & Patient Recruitment
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Thank you for managing my recruitment to AbbVie for the Associate Director, Global Project Management position. I appreciate all the efforts that you and your company accomplished in helping me secure this new opportunity. Please know that I would never have known about this opportunity or pursued it without the persistence of Chris. It was your ability with Human Resources and the hiring manager at AbbVie that expedited and helped secure this position for me—I could not have done this without you. Thank you very much!
- Associate Director Project Management
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I have had the pleasure of working with Ilanna. She expresses incredible knowledgeable of the pharmaceutical industry. Ilanna has deep understanding of the jobs she recruits for and consistently provides feedback. Her honest, detailed, direct, and sincere approach is what makes her stand out from the rest.
- Manager Product Development
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Lee Golodny was the recruiter who eventually placed me at my new job. I was looking for a new career opportunity but had not had any success on my own with my networking. Lee contacted me through LinkedIn about a potential job at a small biotech firm. We discussed at length what I was looking for and he walked me through the process. He was very professional and I was impressed with him during the entire process. He followed up with me after every phone call, informal meeting, prepped me for the interview and helped me land a really great opportunity. Looking for a new job can be stressful but he made the process much easier for me. I hope others who may need that extra help will approach Lee to assist them in their job search.
- In vivo Pharmacology and Biomarker Scientist
