20 Best director of regulatory affairs jobs in Boston, MA (Hiring Now!)

Associate Director, Regulatory Affairs
Marengo Therapeutics Inc —Boston, MA
TO ALL AGENCIES: Please, no phone calls or emails to any employee of Marengo about our openings. Marengo Therapeutics, Inc. is an equal employment opportunity…
Estimated: $149K - $188K a year
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4d
Federal Accounts Lead - Pain BU, West
Vertex Pharmaceuticals —Boston, MA
Partner with internal stakeholders including Market Access, Sales, Marketing, Compliance, Legal, Field Operations, HR, and others to provide strategic field…
$166,000 - $250,000 a year
Medical Director, Fertility
The Cooper Companies —United States
Develops and oversees implementation of medical strategy and tactics including scientific communications and publications, annual medical planning, field…
Estimated: $165K - $209K a year
Senior Medical Value Liaison, Neuroscience (Northeast)
Bristol-Myers Squibb —Boston, MA
Serve as an extension of the field leadership team by serving as the point person for strategic field initiatives. Ability to travel 50 to 70%.
Estimated: $182K - $231K a year
Lead Regulatory Affairs Director
Aspartes Pharmaceuticals —Cambridge, MA
This is a leading role, and you will act as the primary source for regulatory strategy and communication with the FDA as well as front the preparation and…
$150,000 - $300,000 a year
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Director, Global Regulatory Affairs, Development Strategy
AstraZeneca —Boston, MA
Providing advice on regulatory issues for both marketed and pipeline products; actively collaborates with management, Global Regulatory Lead and cross…
Estimated: $170K - $215K a year
Senior Director, Head of Business Planning & Operations, Regulatory Affairs
Alexion Pharmaceuticals,Inc. —Boston, MA
This role will also be responsible for proactively supporting the Alexion Regulatory Affairs organization development and strategy, along with supporting key…
Estimated: $201K - $254K a year
Director, Regulatory Affairs, Rare Disease
Ipsen Bioscience, Inc. —Cambridge, MA
Accountable for the development, flawless execution and implementation of regulatory strategies activities for the assigned programs for assigned region or…
$177,000 - $259,600 a year
Lead Consultant, Regulatory Affairs
Clarivate —Boston, MA
Expert knowledge in key areas of responsibility e.g. operating systems, networking technologies, technical standards. Master’s Degree in life sciences.
Estimated: $147K - $186K a year
2d
Director, Regulatory Affairs
Lantheus Medical Imaging Inc —Bedford, MA
Reviews critical analyses of data (clinical, preclinical and manufacturing) and independently develops interpretations and conclusions; performs meaningful…
Estimated: $139K - $176K a year
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Associate Director, Regulatory Strategy
Agios Pharmaceuticals —Cambridge, MA
Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active…
Estimated: $115K - $146K a year
Director, Health Economics & Outcomes Research
Veranex, Inc. —Boston, MA
Offering expert guidance from concept-through-commercialization, including product design and engineering, preclinical and clinical development, data management…
$152,800 - $218,460 a year
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12d
Senior Director, Head of Business Planning & Operations, Regulatory Affairs
AstraZeneca —Boston, MA
Ability to influence and develop a network across the Enterprise. This role will also be responsible for proactively supporting the Alexion Regulatory Affairs…
Estimated: $206K - $261K a year
Director, Regulatory Affairs
Relay Therapeutics —Cambridge, MA
You will report to our Head of Regulatory Affairs and work side by side with your research and development colleagues to develop and execute innovative…
Estimated: $136K - $173K a year
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Associate Director Regulatory Affairs Oncology
EMD Serono —Billerica, MA
Ensure optimal planning in alignment with cross-functional team, and execution to plan for both development submissions and maintenance submissions to ensure…
Associate Director, Regulatory Affairs Advertising & Promotion
Argenx —Boston, MA
Understands business goals and common marketing concepts/tools. Provides regulatory strategic oversight for at least one (1) complex product or therapeutic area…
Estimated: $145K - $184K a year
Senior Director of Programs
Office of Consumer Affairs and Business Regulation —Boston, MA
The SDP is one of the official keepers of records for the Programs and must ensure compliance with the state and federal laws, including the state public…
$99,000 - $120,000 a year
Associate Director / Director, Regulatory Operations & Affairs
Treeline Biosciences —Watertown, MA
Bachelor's degree in life sciences, pharmacy, or a related field with a minimum of 7-10 years of experience in oncology regulatory affairs within the…
Estimated: $128K - $162K a year
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12d
Associate Director, Regulatory Strategy
Vertex Pharmaceuticals —Boston, MA
Comprehensive understanding of drug development and related concepts, such as clinical trial design, statistics, and clinical pharmacology.
Estimated: $166K - $210K a year
3d
Senior Director, Head of Drug Substance
Astria Therapeutics Inc —Cambridge, MA
Ph.D. in biochemical engineering, chemical engineering, biochemistry, or appropriate technical discipline with 12-15 years industrial bioprocess development…
Estimated: $170K - $215K a year
Quick Apply
6d

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Associate Director, Regulatory Affairs

Marengo Therapeutics Inc Boston, MA

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Job Details

Full-time Estimated: $149K - $188K a year 4 days ago

Benefits

Free parking
Disability insurance
Health insurance
Dental insurance
Flexible spending account
Vision insurance
401(k) matching
Life insurance

Qualifications

Biotechnology
Medicine
Doctoral degree
Visual Basic
Writing skills
Master's degree
Bachelor's degree
Doctor of Philosophy
Immunology
Organizational skills
Pharmacy
Budgeting
Oncology
Communication skills
Product lifecycle management

Full Job Description

Marengo Therapeutics, Inc., a clinical-stage biotech company, develops novel TCR-targeting antibodies that selectively modulate common and disease-specific T cell subsets of the germline TCR repertoire to provide lifelong protection against cancer and other diseases. With a passionate team of dedicated scientists experienced in immunology and oncology, Marengo's proprietary Selective T Cell Activation Repertoire (STAR) platform leverages an extensive biological understanding of T cell function and receptor signaling to create a world in which everyone's immune system can defeat cancer. To learn more, visit marengotx.com.

About STAR0602

STAR0602 is Marengo's lead program, the first selective T cell activator generated from Marengo's STAR platform, a library of antibodies targeting non-clonal variable (V)ß regions of the TCR fused to different co-stimulatory moieties. STAR0602 selectively targets a common Vb T cell subset present in all cancers and, by combining a novel non-clonal mode of TCR activation with a T cell co-stimulator in the same molecule, promotes expansion of a new population of clonally enriched, effector memory Vb T cells that turbo-charge immune system and promote a durable anti-tumor immune response. STAR0602 has undergone extensive preclinical testing, which demonstrates potent anti-tumor activity in both mouse and human ex vivo tumor models attributed to a distinct mechanism of action from existing cancer immunotherapies.

Role: Associate Director, Regulatory Affairs

Purpose of the role:

Reporting to the Chief Development Officer, this team member will play a key role in Marengo's regulatory organization/team. The Associate Director of Regulatory Affairs will oversee daily regulatory affairs activities, including the areas of clinical research, CMC, regulatory operations, nonclinical study requirements, and regulatory compliance to support the successful development, approval, and marketing of Marengo products. The ideal candidate for this role is an experienced, natural self-starter with strong organizational skills who thrives in a busy, fast-paced environment and can communicate effectively with all levels of our organization and our external partners and customers.

Who are we looking for?

You are an energetic and passionate regulatory professional who likes to think outside of the box, challenge the norm, and is passionate about the company's mission of discovering and developing new medications
You are a resourceful self-starter and team player with a strong result orientation
You consider yourself as well versed in all the corporate REGULATORY AFFAIRS in a clinical-stage organization
You can develop trusting relationships to gain support and achieve results at all levels of the organization

What are we looking for?

A driven professional who knows how to work and contribute to an ever-changing working environment
A collegial individual who enjoys working in close collaboration with leaders in the research, development, quality, clinical, and administrative areas of the company
A willingness to learn new things, adapt to new ways, and go with the flow
A person who thrives in a small company atmosphere
Ability to determine task priority and maintain established deadlines

What are we offering?

Reporting to a Regulatory Guru, who has an extensive track of accomplishments
Membership within a growing, CARING, and collegial organization
Being part of a passionate, involved, and cutting-edge Development Team
Exposure to pioneering science and the discovery of drugs to help treat patients with cancer

IF YOU ARE INTERESTED IN APPLYING, PLEASE READ ENTIRE POSTING

Responsibilities:

Work closely with Marengo's Development & Clinical Teams to execute regulatory objectives that result in the successful entry of Marengo's assets to the clinic, their development, marketing approvals, and post-approval commercialization.
Manage (Project Management) the preparation and timely submission of regulatory documentation to support global investigational and marketing application packages.
Accompany our CDMO in meetings with regulatory agencies/authorities; lead the preparation of meeting documents (e.g., requests, meeting packages); virtual meetings, and other communications (e.g., Marengo's responses to information requests) with FDA and other regulatory agencies/authorities.
Provide execution in preparation for regulatory interactions and negotiation with global regulatory agencies/authorities to resolve key regulatory issues critical to the successful development of Marengo's portfolio.
Maintain the expertise with the most updated knowledge on regulations and regulatory guidance documents from global regulatory agencies/authorities such as FDA, EMA, and ICH; make high-quality regulatory recommendations to Marengo's senior leadership and cross-functional teams; and ensure adherence to these regulatory guidance and regulations as well as Marengo's internal procedures.
Manage external regulatory vendors/consultants as needed.

Education and Experience:

Bachelor's degree in life sciences discipline (Biology, Chemistry, Engineering), MS/PhD/MD/PharmD preferred.
More than 8 years of biotechnology or pharmaceutical industry experience, preferably at least 5 years of immuno-oncology experience.
Knowledge and understanding of drugs/biologics development process, regulatory requirements, regulations, and regulatory guidance.
Regulatory experience with INDs/CTAs, NDAs/BLAs/MAAs, and product lifecycle management.
Demonstrated skills and experience in interactions with regulatory authorities.
Excellent writing, interpersonal communications, organizational, and presentation skills. Demonstrated experience with budgeting and planning.
The candidate should be capable of operating with a high level of autonomy and will be responsible for the operational details and execution. This is a hands-on role. We are looking for a "do-er"!

Competencies:

Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty.

Collaboration: Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others. Involves others in decisions and plans and credits them for their contributions and accomplishments.

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high-quality results, and accelerating business performance. Addresses problems directly and drives changes necessary to achieve business objectives.

Relationship Building: Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity, and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity.

Location: Cambridge, MA (We are located in Lower Cambridge)

When You Join Marengo, You Will Have:

Free parking, Cambridge location reachable by public transportation (Red Line)
Customized and competitive health coverage, including medical offered through BCBS (PPO), dental, and vision
Flexible Spending Accounts for medical and dependent care expenses
Eligible from the first day for 401K, no matching
A robust package of Marengo-paid insurance coverage, including life insurance, short-term and long-term disability
20 days of vacation and one personal day per year, in addition to 13 company holidays

TO ALL AGENCIES: Please, no phone calls or emails to any employee of Marengo about our openings. All resumes submitted by search firms/employment agencies to any employee at Marengo via email, the internet or in any form and/or method will be deemed the sole property of Marengo unless such search firms/employment agencies were engaged by Marengo for this position and a valid agreement with Marengo is in place. In the event a candidate who was submitted outside of the Marengo agency engagement process is hired, no fee or payment of any kind will be paid.

Marengo Therapeutics, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service or any other class protected by state or federal law.

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director of regulatory affairs jobs in Boston, MA

Associate Director, Regulatory Affairs

Federal Accounts Lead - Pain BU, West

Medical Director, Fertility

Senior Medical Value Liaison, Neuroscience (Northeast)

Lead Regulatory Affairs Director

Director, Global Regulatory Affairs, Development Strategy

Senior Director, Head of Business Planning & Operations, Regulatory Affairs

Director, Regulatory Affairs, Rare Disease

Lead Consultant, Regulatory Affairs

Director, Regulatory Affairs

Associate Director, Regulatory Strategy

Director, Health Economics & Outcomes Research

Senior Director, Head of Business Planning & Operations, Regulatory Affairs

Director, Regulatory Affairs

Associate Director Regulatory Affairs Oncology

Associate Director, Regulatory Affairs Advertising & Promotion

Senior Director of Programs

Associate Director / Director, Regulatory Operations & Affairs

Associate Director, Regulatory Strategy

Senior Director, Head of Drug Substance

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