Senior Vice President, Head of Global Regulatory Affairs
4 weeks ago
Are you a seasoned Senior Regulatory Leader looking for a new and exciting challenge? Beacon Therapeutics (USA) Inc is seeking a talented individual to join us as a Full Time Senior Vice President, Head of Global Regulatory Affairs, completely remote In this role, you will have the opportunity to lead our global regulatory strategy and drive submissions for innovative biotech products.
The pay for this position is competitive and commensurate with experience. Join us in Boston, MA, and be part of a forward-thinking and professional team dedicated to making remarkable advancements in the biotech industry. Apply today and You will be offered great benefits such as Medical, Dental, Vision, 401(k), Life Insurance, Health Savings Account, Flexible Spending Account, Competitive Salary, and Paid Time Off. take your regulatory career to new heights with us
A little about usIf you're passionate about gene therapy and its ability to enhance the lives of patients, then Beacon is a great team to join. We're a diverse, multi-national team of talented people all working together at our sites in the US and the UK, or as a remote contributor. Everyone here, whatever their role or location, plays a genuine part in bringing our treatments to patients. Everyone has a voice, and every contribution makes a difference.
Make a difference as a Senior Vice President, Head of Global Regulatory AffairsAs the Head of Global Regulatory Affairs at Beacon Therapeutics (USA) Inc, you will play a pivotal role in shaping the company's direction by leading the Regulatory and Compliance strategy. Your innovative solutions and strategic contributions will drive the Regulatory Team toward excellence and ensure compliance in all aspects of our operations. Join our dynamic team and be part of a collaborative and forward-thinking environment where your leadership will make a significant impact on the biotech industry.
Does this sound like you?To excel in the role of Head of Global Regulatory Affairs at Beacon Therapeutics (USA) Inc, candidates must possess a strategic and solution-oriented mindset. Demonstrated knowledge of IND and CTA regulatory requirements, along with a solid understanding of the Regulatory framework in the US and EU, is essential. Experience in gene therapy and ophthalmology will be advantageous. Strong negotiation and influencing skills, coupled with clear and adaptable communication tailored to various audiences, are vital. The ability to synthesize vast amounts of information into a coherent and concise narrative will be key to success in this position.
Join us and showcase your skills in a professional and innovative remote work environment.
Knowledge and skills required for the position are:
- Strategic and solution oriented
- Knowledgeable of IND and CTA regulatory requirements
- Working knowledge of Regulatory framework in US and EU
- Experience with gene therapy and ophthalmology
- Negotiation and influencing skills
- Clear communication adapted to the audience
- Ability to synthesize a lot of information into a concise and clear story
If this sounds like the right job for you, don't wait - apply today to join our team. We look forward to hearing from you
-
Cambridge, MA, United States Beacon Therapeutics (USA) Inc Full timeAre you a seasoned Senior Regulatory Leader looking for a new and exciting challenge? Beacon Therapeutics (USA) Inc is seeking a talented individual to join us as a Full Time Senior Vice President, Head of Global Regulatory Affairs, completely remote! In this role, you will have the opportunity to lead our global regulatory strategy and drive submissions...
-
Senior VP of Medical
1 week ago
Cambridge, MA, United States Beacon Therapeutics (USA) Inc Full timeAre you a seasoned Senior Regulatory Leader looking for a new and exciting challenge? Beacon Therapeutics (USA) Inc is seeking a talented individual to join us as a Full Time Senior Vice President, Head of Global Regulatory Affairs, completely remote! In this role, you will have the opportunity to lead our global regulatory strategy and drive submissions for...
-
Vice President, Patient Affairs
2 weeks ago
Cambridge, United States Astria Therapeutics Inc Full time**Position Overview**: Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the treatment of hereditary angioedema, as...
-
Head of Global Medical Affairs
1 week ago
Cambridge, United States Bicycle Therapeutics Full time**Company Description** Bicycle Therapeutics (NASDAQ: BCYC) is a clinical-stage biopharmaceutical company developing a novel class of medicines. Our pipeline includes Bicycle Toxin Conjugates® as well as fully synthetic Bicycle® systemic immune cell agonists and Bicycle tumor-targeted immune cell agonists (Bicycle TICAs) focused on oncology indications...
-
Manager of Regulatory Affairs
1 week ago
Cambridge, United States PSG Global Solutions Full timeDescription We're looking for a Manager of Regulatory Affairs , working in Biotechnology/Medical Devices industry in Cambridge, Massachusetts, United States . Works with Regulatory Affairs management to define regulatory strategy and to compile and submit, in a timely manner, regulatory documents according to regulatory requirements. Develops detailed...
-
Vice President, Head of Safety
2 weeks ago
Cambridge, United States Astria Therapeutics Inc Full time**Position Overview**: Astria is seeking an innovative and collaborative individual who will play a pivotal role in fostering a culture of safety within the company ensuring that Astria remains at the forefront of patient safety and pharmacovigilance. The individual will be responsible for the strategic implementation, execution, and management of...
-
Head of Global Medical Affairs
1 week ago
Cambridge, United States Bicycle Therapeutics Full timeJob DescriptionJob DescriptionCompany DescriptionBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two...
-
Head of Global Medical Affairs
1 week ago
Cambridge, United States Bicycle Therapeutics Full timeJob DescriptionJob DescriptionCompany DescriptionBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two...
-
Head of Global Medical Affairs
2 weeks ago
Cambridge, United States Bicycle Therapeutics Full timeCompany DescriptionBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their...
-
Head of Global Medical Affairs
2 days ago
Cambridge, United States Bicycle Therapeutics Full timeCompany DescriptionBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their...
-
Senior Manager, Regulatory Affairs
1 month ago
Cambridge, United States Relay Therapeutics Full timeThe Opportunity: We are looking for a strategic regulatory leader to join our growing regulatory team at Relay Tx. You will have the opportunity to help define and implement innovative regulatory strategies to expedite the development and approval of our transformative pipeline. You will serve as the regulatory representative on relevant project teams and...
-
Head of Global Medical Affairs
2 weeks ago
Cambridge, United States Bicycle Therapeutics Full timeBicycle Therapeutics is a clinical-stage biopharmaceutical company developing a novel class of medicines, referred to as Bicycle® molecules, for diseases that are underserved by existing therapeutics. Bicycle molecules are fully synthetic short peptides constrained with small molecule scaffolds to form two loops that stabilize their structural geometry....
-
Senior Manager, Regulatory Affairs
1 week ago
Cambridge, United States Editas Medicine Full timeAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...
-
Senior Manager, Regulatory Affairs
1 week ago
Cambridge, United States Editas Medicine Full timeAt Editas, we're driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...
-
Senior Manager, Regulatory Affairs
1 month ago
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
-
Senior Manager, Regulatory Affairs
4 weeks ago
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
-
Senior Manager, Regulatory Affairs
2 days ago
Cambridge, United States Editas Medicine Full timeJob DescriptionJob DescriptionAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing....
-
Manager of Regulatory Affairs
2 weeks ago
Cambridge, United States PSG Global Solutions Careers Full timeApply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Manager of Regulatory Affairs, working in Biotechnology/Medical Devices industry in Cambridge, Massachusetts, United States. Works with Regulatory Affairs management to define regulatory strategy and to compile and...
-
Manager of Regulatory Affairs
1 day ago
Cambridge, United States PSG Global Solutions Careers Full timeApply now and our proprietary system will quickly have you in front of a live recruiter. The Opportunity Description We're looking for a Manager of Regulatory Affairs, working in Biotechnology/Medical Devices industry in Cambridge, Massachusetts, United States. Works with Regulatory Affairs management to define regulatory strategy and to compile and...
-
Senior Manager, Regulatory Affairs CMC
3 weeks ago
Cambridge, United States Sarepta Therapeutics Full timeThe Senior Manager, Regulatory Affairs CMC supports RA CMC gene therapy development product(s) and provides support for Chemistry, Manufacturing and Controls (CMC) Regulatory Affairs. They will work closely with subject matter experts within CMC technical operations and QA working within a CMC sub-team structure and serving as a member of the GRT. The Senior...