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Associate Director of RA CMC – Cambridge

Regulatory Connect has partnered with an Innovative Biopharma Start-up based in Cambridge MA. They were recently voted by Fierce Pharma as 'the hottest start-up in Cambridge' due to their portfolio of autoimmune disease, blood cancer, and rare genetic diseases.


Location – Cambridge Massachusetts

Description:

You will work directly with the VP of RA who is one of the most respected Regulatory figures in Cambridge so this is a great opportunity to learn first hand from one of the industry leaders. She is massively engaging, ego-free and has a wealth of knowledge to share.


If you are looking to advance your CMC career with a really exciting company who have excellent work life balance (they leave at 5pm) then this is a great opportunity. This would suit anyone who want to work in a massively collaborative exciting environment who does not want to burn out their employees, they want you to have a life outside the office!


This role provides the rare opportunity for a growing professional to develop their skills through collaboration with the senior-most levels of the organization while making strategic and tactical impact on the things that matter most – driving our science to help patients.


Responsibilities:


Day-to-day management of regulatory submissions to include filings maintenance, CMC writing, modules processing and circulating for review and approval of all submission deliverables· 

Participating in day-to-day meetings/committees / regulatory interactions and providing input to regulatory submission deliverables and objectives as needed to meet the corporate goals· 

Assess proposed analytical and manufacturing changes for impact on regulatory filings· 

Working with Regulatory, Quality and CMC management to implement internal electronic systems for various documentation workflows and repositing· 

Collaborating cross-functionally with all relevant areas to support corporate objectives.


Qualifications & Skills:

-BS/BA Degree in a biology or related discipline, advanced degree a plus

-5 to 8 years of relevant experience in regulatory submissions for small molecules, biologics or cell therapies preferred, with a focus on CMC. 

-Experience with ADC products a plus.· 

-Fundamental knowledge of eCTD requirements for submission to US and exUS regulatory agencies (IND, IMPD, BLA, NDA, MAA).·

-In-depth experience using electronic environments for submissions/documentation management.·

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Director Regulatory Affairs - Boston 

The Director of Regulatory Affairs will be accountable for leading the development and execution of global regulatory strategies for innovative medicines for rare diseases. A successful candidate will maintain focus on corporate goals while responding to the needs of project teams in a highly dynamic, fast-moving environment. 


Location – Cambridge Massachusetts

Responsibilities:


- Initiate and lead the development of competitive regulatory strategies that expedite development, maximize the probability of success, and mitigate risks. Ensure regulatory requirements and strategy are understood by project teams.


- Preparation, review and submission of high-quality documentation for INDs, CTAs, NDAs, BLAs, MAAs, and related filings to Regulatory Agencies within established timeframes.


- Serve as FDA liaison and provide leadership and support for Regulatory Agency meetings and teleconferences.

- Maintain up-to-date knowledge on international and domestic regulatory requirements.


Qualifications & Skills:


- 10+ years of increasing responsibility in pharmaceutical or biotech.


- Rare disease experience preferred


- Track record of successful IND, CTA, NDA, and/or BLA submissions


- Ability to blend analytical and critical-thinking skills to enable data-driven, strategically oriented review of regulatory documents




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Senior RA CMC Manager / Director- Homebased


Regulatory Connect has partnered with a Biopharma Start-Up who have a strong early stage development pipeline with 17 IND's/CTA's globally and over 1 billion of private funding. They are opening a second office in New Jersey to ensure successful registration of their products. This RA CMC role can be offered fully home-based (must be based on East-Coast) at any level from Manager to Senior Director dependent on the candidate's experience.


This position would suit anyone with strong RA CMC Development experience with regards to IND's (NDA experience a plus) in the area of Oncology


Location – Home-based


Responsibilities:


-Lead the regulatory CMC strategy for the assigned clinical products Interact with FDA regarding Regulatory CMC.

-Contribute to the development and implementation of short and long-term regulatory strategies for assigned projects and programs.

-Plan, prepare and review regulatory authority submissions (CMC supplements, amendments, Agency meeting requests) for assigned projects to ensure alignment with Health Authority requirements.

-Be the in-house expert for all Regulatory CMC issues.


About the comapny:

They currently have more than 250 employees, including 160 world-class scientific researchers and clinicians, and their founding leadership team has been pioneering apoptosis-targeted drug innovation for more than two decades. With their proprietary design platform, robust product pipeline, and commitment to excellence, they are well positioned to deliver first- and best-in-class therapies that can transform the lives of patients around the world.

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Senior RA Project Manager - Homebased 

Regulatory Connect has partnered with an Innovative Biopharma Start-up based in NJ. They are an extremely well-funded start-up with over a billion of Funding and 17 global IND's/CTA's. They have recently opened an office in NJ but this role can be offered fully home-based.

Description:


They are registering 5 IND's in the US and are looking for 2 Project Managers/Associate Director/Director who can lead 2 IND's each and have experience being the FDA primary contact.

You will have worked in development teams and will have US + EU experience. Oncology experience is a real plus.


There is an excellent salary, equity etc.. on offer and the chance to help take a product from IND to NDA. You will report to the Head of Regulatory and will learn a huge amount in a massively collaborative environment.

Applicants must have: 


- Regulatory PM experience
- Have worked with IND's
- Ideally, have Oncology
- Be based on the East Coast

This role provides the rare opportunity for a growing professional to develop their skills through collaboration with the senior-most levels of the organization while making strategic and tactical impact on the things that matter most – driving our science to help patients.







Apply for this position now.

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