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$129k–$210k/yr
Full-time
postgraduate degree
Annual Bonuses, Incentive Plans, Equity Awards, Pension, Retirement Benefits, 401(k) Company Match
Posted 20d ago
~40 hrs/week
Responsibilities
Coordinate the preparation and management of global regulatory submissions including INDs, CTAs, and Orphan drug applications. Support the Global Regulatory Liaison in ensuring compliance across preclinical and clinical areas of drug development.
Requirements
Requires a minimum of an MD, PhD, or PharmD degree with at least 2 years of regulatory experience. Candidates should have a strong understanding of US FDA and international pharmaceutical regulations and experience with regulatory filings.
Full job description
Build our future together:
At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Manager to join our Regulatory Affairs Strategy Oncology team. The Manager, Regulatory Affairs will report to the Global Regulatory Liaison (GRL) and provides support to the GRL in all aspects of regulatory affairs related to the development of novel therapeutics including quality, preclinical and clinical areas of drug development and the policies/procedures required to ensure compliance with regulations.
This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
When & where:
Work Location: Tarrytown, NY or Warren, NJ
Hybrid; 4 days per week on site
Discover your role:
Coordinate the preparation, submission, management and maintenance of global regulatory submissions related to clinical and nonclinical aspects of product development, including, but not limited to, the following: INDs/CTAs, amendments and information requests, Orphan drug applications, Annual Reports and Investigator’s Brochure
Assist in coordination and preparation for Agency meetings and associated briefing document preparation
Leads and tracks queries and commitments with regulatory agencies, collaborates with subject matter experts to provide written responses to queries, provides periodic status updates regarding conditions/commitments
Provide representation for study-level regulatory activities and participate in cross-functional departmental team projects and product development activities/meetings
This role requires:
Minimum MD, PhD or PharmD degree along with 2+ years of regulatory experience.
We expect to see individuals have worked on filings, helped with developing regulatory related documents and engaged with external partners and authorities.
If you bring good understanding of US FDA and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
If you are interacting with CROs in the management of ex-US/ex-EU CTAs towards clinical trial activations preferred
If you have a high attention to detail; ability to coordinate and prioritize assigned projects according to company goals
You bring strong interpersonal skills both written and verbally
Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.
Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process. If you have any questions, please speak with your recruiter.
Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.
As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.
For jobs in Canada: this posting is for an existing position.
At Regeneron we believe that when the right idea finds the right team, powerful change is possible. As we work across our expanding global network to invent, develop and commercialize life-transforming medicines for people with serious diseases, we’re establishing new ways to think about science, manufacturing and commercialization. And new ways to think about health. Connect with us so we can learn more about you, and you can learn more about our biopharmaceutical medicines. And join us, as we build a future we believe in.
Please visit www.regeneron.com/social-media-terms for information on how to engage with us on social media.
An important note about privacy: Regeneron is committed to your privacy and will not ask for sensitive personal information such as social security number, date of birth or bank account details via email or social media.
Offices: 777 Old Saw Mill River Road, Tarrytown, New York 10591, US · 81 Columbia Turnpike, Rensselaer, New York 12144, US · 110 Allen Road, Basking Ridge, New Jersey 07920, US · 1 Rockwood Rd, Sleepy Hollow, New York 10591, US · 2425 Matheson Blvd E, Suite 726, Mississauga, Ontario L4W 5K4, CA
Based on 1607 listings with disclosed salaries, most healthcare jobs in Georgia pay between $70k–$164k per year. Individual offers vary with seniority, company size, and specialization.
How many Healthcare jobs are open in Georgia right now?
There are currently 17,867 open healthcare positions in Georgia listed on Clera. New openings are added daily as companies post roles.
Which companies are hiring for Healthcare roles in Georgia?
Companies currently hiring include PruittHealth, Northside Hospital, Piedmont HealthCare, Emory Healthcare, Wellstar Health System, among others. Browse the listings above to see every active employer.
Are there remote or hybrid Healthcare jobs in Georgia?
Yes — 1511 of the 17867 open healthcare positions offer remote or hybrid work (577 remote, 934 hybrid).
How do I apply for Healthcare jobs in Georgia?
Each listing links directly to the employer's application page. Apply early — fresh listings get the most recruiter attention in the first two weeks.