Current jobs related to Senior Manager/Associate Director, Regulatory Affairs - Boston, Massachusetts - Alpha-9 Oncology
-
Boston, Massachusetts, United States enGene Full timeenGene (NASDAQ: ENGN) is a late-stage biotechnology company, mainstreaming genetic medicines through the delivery of therapeutics to mucosal tissues and other organs, whose lead product candidate, detalimogene voraplasmid, is being evaluated in an ongoing pivotal study for patients with non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (Cis)...
-
Director, Medical Affairs
2 days ago
Boston, Massachusetts, United States PepGen Full time $183,000 - $274,000PepGen is hiring a Director, Medical Affairs to lead the development and execution of the company's global medical affairs strategy. This role will play a critical leadership position within Medical Affairs and will have close crossover with Patient Advocacy, Clinical Development, Regulatory, and Corporate Communications. Reporting to the Vice President,...
-
Boston, Massachusetts, United States Vor Bio Full timeJoin Us in Tackling Autoimmune Disease at Its RootAt Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades. Together, we are addressing...
-
Boston, Massachusetts, United States TakedaPharmaceutical Nordics AB Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and thatthe information I provide in my application will be processed in line withTakeda'sPrivacy Noticeand Terms of Use.I further attest that all information I submit in my employment applicationistrue to the best of my knowledge.Job...
-
Chief External Affairs Officer
2 days ago
Boston, Massachusetts, United States YMCA of Greater Boston Full time $225,000 - $250,000Chief External Affairs OfficerDepartment: OperationsEmployment Type: Full TimeLocation: Huntington YMCAReporting To: CEOCompensation: $225,000 - $250,000 / yearDescription POSITION SUMMARY:Grounded in equity, belonging, community voice, and meaningful partnership, the CEAO is a first-time role at YGB. The CEAO will ensure that YGB's narrative, priorities,...
-
Associate Director, Safety Scientist
1 week ago
Boston, Massachusetts, United States AstraZeneca Full timeThe Associate Director, Safety Scientist plays a leadership role within Global Patient Safety (GPS) to actively evaluate and manage risk in collaboration with the GPS Medical Director(s) and cross-functional team members within the global regulatory framework.You will be responsible for:Managing safety scientist activities across multiple product portfolios...
-
Regulatory Counsel
1 week ago
Boston, Massachusetts, United States Environmental League of Massachusetts (ELM) Full timeReporting to:Vice President of Policy and Regulatory AffairsSupporting:ELM and the ELM Action FundSalary Range: $110,000-$130,000The Environmental League of Massachusetts (ELM) and the ELM Action Fund (ELM AF) are seeking an experienced regulatory attorney to drive our work at the Department of Public Utilities and our related advocacy. Regulatory Counsel is...
-
Senior Manager Health Economics
2 days ago
Boston, Massachusetts, United States AstraZeneca Full time $113,000 - $170,000This is what you will do: The Senior Manager, US Health Economics and Outcomes Research is a mid-entry level role on the US HEOR Real World Evidence (RWE) Team, based out of our Boston Headquarters. The Senior Manager, US HEOR RWE assists with the submission and assumes project owner status of US HEOR material within the internal Medical, Legal, and...
-
Head of Corporate Affairs, US
2 days ago
Boston, Massachusetts, United States Primark Full timeHead of US Corporate AffairsPrimark USA is growing: A decade after it opened its first store, the international retailer now has 34 stores in 13 states and 17 further leases already signed. The Head of Corporate Affairs, US, will lead Primark's reputation and communications strategy in the US, spanning external and internal communications, public affairs,...
-
Commercial Credit Risk Senior Director
2 days ago
Boston, Massachusetts, United States Citizens Full time $220,000 - $340,000Commercial Credit Risk Senior DirectorWe are seeking a dynamic and experienced credit executive to lead the Commercial & Industrial (C&I) Credit Risk function for the Corporate Banking division. This role is responsible for managing credit risk across all industry verticals, including, but not limited to industrials, energy, transportation, technology,...
Senior Manager/Associate Director, Regulatory Affairs
4 days ago
Your Impact
Alpha-9 Oncology is seeking an accomplished Senior Manager/Associate Director, Regulatory Affairs to lead global regulatory strategy and operations across our growing radiopharmaceutical pipeline. In this role, you will advance early- and mid-stage programs by shaping regulatory strategy, ensuring compliance, and building the systems and processes needed to scale a global regulatory function.
You will have the opportunity to take ownership of regulatory operations, manage submissions, interact with health authorities, and establish standards that will guide Alpha-9 for the future.
How You'll Contribute
- Lead the development and execution of regulatory strategies to support development milestones and interactions with health authorities.
- Prepare, submit, and maintain global regulatory filings including INDs, CTAs, amendments, annual reports, and safety updates.
- Design and implement submission workflows, document control processes, and systems to ensure accuracy, consistency, and inspection readiness.
- Support or lead the preparation of briefing materials and participate in meetings with regulatory agencies.
- Track and manage agency queries and commitments, coordinating responses and update across functional teams.
- Collaborate closely with Clinical Development, CMC, and Quality teams to ensure submissions and strategies are aligned with program objectives.
- Monitor evolving regulations and guidance, keeping teams informed and driving continuous process improvements.
The Skills You Bring
- Bachelor's degree in Life Sciences, Pharmacy, or a related field required; advanced degree (Ph.D., Pharm.D., or equivalent) preferred.
- Minimum of 5+ years of experience in regulatory affairs within biotechnology or pharmaceutical development, with a focus on global submission management.
- Proven experience managing global regulatory submissions (INDs, CTAs, amendments, annual reports) and interfacing with global health authorities such as FDA, EMA, TGA, and Health Canada.
- Skilled in implementing and managing regulatory processes and electronic submissions using RIM/EDMS tools (e.g., Veeva).
- Solid understanding of early-phase drug development, including CMC, nonclinical, and clinical components.
- Demonstrated experience authoring or reviewing regulatory submission documents and contributing to regulatory strategy development.
- Strong project management and communication skills, with the ability to collaborate effectively across cross-functional teams in a fast-paced environment.
- Experience in radiopharmaceuticals, radioligand therapies (RLTs), or oncology is preferred.
What's In It For You
At Alpha-9 Oncology, we offer a competitive and comprehensive benefits package designed to support all employees. Our benefits include a competitive salary, bonus, equity, 20 vacation days, 5 sick days, a technology allowance, and commuter reimbursement. We also provide generous retirement savings plans with employer matching, extended health benefits, and paid holidays, tailored to local standards in each region. While specific offerings may vary by location, our commitment to fostering a supportive and rewarding work environment is consistent across the company.
Pay Transparency Statement Alpha-9 Oncology is committed to pay transparency and equitable compensation. This position may be filled at one of two levels, depending on the candidate's experience, qualifications, and overall fit. Final compensation will reflect the responsibilities of the selected level and will consider factors such as education, experience, and internal equity.In addition to base salary, this role includes eligibility for an annual performance bonus, participation in our equity incentive plan, and a comprehensive benefits package.
Per Year Salary Range: $148,000 USD - $200,000 USD
Company Summary
Alpha-9 Oncology is a clinical-stage biotechnology company pioneering radiopharmaceutical innovation for solid tumors. Our proprietary scaffolds, composed of optimized binders, linkers, chelators, and radioisotopes, enable targeted radiation delivery to cancer cells, minimizing harm to surrounding healthy tissue. Focusing on innovative targeting moieties, we develop molecules tailored for precise tumor targeting.
Our comprehensive platform integrates imaging and therapeutic studies to ensure effective radiation delivery and improved patient outcomes. With a robust pipeline entering clinical trials and strong support from leading healthcare investors, Alpha-9 is positioned for rapid growth and advancement in cancer therapy.
More About Alpha-9 Oncology
Alpha-9 Oncology is committed to fostering a diverse and inclusive workplace and is proud to be an Equal Opportunity Employer. We provide employment opportunities to all qualified applicants without regard to race, ethnicity, religion, age, sex, gender identity or expression, sexual orientation, disability, marital status, family status, national origin, or any other characteristic protected by applicable federal, provincial, or local laws where we operate.
We are dedicated to providing reasonable accommodations to qualified applicants and employees to ensure that everyone can perform their essential job functions in an inclusive environment. For inquiries regarding accommodations in the hiring process or for current employees, please contact a member from our Talent Acquisition team.
