Top 13 Regulatory affairs Jobs in Fishkill, Ny

(Senior) Patient Safety Physician, Medical Safety Physician - CRM
BI Pharmaceuticals, Inc. —Ridgefield, CT
- $280,000 - $394,000 a year
- Full-time
- Medicine
- BC/BE
- Research
Lead Patient Safety Physician - CRM
BI Pharmaceuticals, Inc. —Ridgefield, CT
- Full-time
- Medicine
- BC/BE
- Senior level
(Senior) Patient Safety Physician, Medical Safety Physician - Oncology
BI Pharmaceuticals, Inc. —Ridgefield, CT
- $280,000 - $394,000 a year
- Full-time
- Medicine
- BC/BE
- Research
Senior Associate Director, Medical Affairs Strategy Team Member - Respiratory (Hybrid)
BI Pharmaceuticals, Inc. —Ridgefield, CT
- Full-time
- 18 years or older
- Medicine
- 7 years
Senior Associate Director, Medical Affairs Strategy Team Member - Pulmonary ILD (Hybrid)
BI Pharmaceuticals, Inc. —Ridgefield, CT
- Full-time
- 18 years or older
- 7 years
- Bachelor of Science
AD / Senior AD, Clinical Pharmacology Lead - Remote
BI Pharmaceuticals, Inc. —Ridgefield, CT
- $140,000 - $269,000 a year
- Full-time
- 18 years or older
- Medicine
- Pass drug screening
Director, Regulatory Affairs – CMC
Rocket Pharmaceuticals —United States
- $204,000 - $264,000 a year
- Full-time
- Bachelor of Science
- 8 years
- Bachelor's degree
- Paid holidays
- Health insurance
Vice President of Compliance
Scott & Associates, PC —United States
- Full-time
- Remote
- Data analysis skills
- HIPAA
- Finance
Senior Manager/Associate Director, Regulatory CMC Consultant (REMOTE)
Kaztronix —United States
- Contract
- Remote
- 6 years
- Management
- Bachelor's degree
Quick Apply
Senior Medical Science Liaison (Nephrology) - Lower Manhattan, Brooklyn, Staten Island, Long Island
Vertex Pharmaceuticals —United States
- $171,300 - $256,900 a year
- Full-time
- English
- Mentoring
- Data entry
- Loan repayment program
- Health insurance

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Quality Control Supervisor
Hudson Valley Lighting Group —Wappingers Falls, NY
This role is responsible for overseeing daily QC operations while actively contributing to the assembly, rework, and repair of lighting fixtures and displays in…
$25.00 - $26.44 an hour
Quick Apply
SQF Manager
Aladdin Packaging LLC —Newburgh, NY
Lead preparation, coordination, and follow-up for SQF certification audits and customer audits. Have HACCP certification and SQF training.
$70,000 - $75,000 a year
Quick Apply

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Manager, Regulatory Affairs
Victoria's Secret —Reynoldsburg, OH
Experience improving processes, implementing tools, or driving operational efficiencies. Bachelor’s degree in a relevant field.
$112,700 - $153,720 a year
Manager, Regulatory Affairs
The Scotts Miracle-Gro Company —Marysville, OH
Provide strategic oversight navigating complex state-by-state variations in fertilizer labeling requirements. As a regulatory leader, you will directly manage a…
$111,500 - $131,200 a year

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(Senior) Patient Safety Physician, Medical Safety Physician - CRM

BI Pharmaceuticals, Inc. -
Ridgefield, CT

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Job Details

Full-time
$280,000 - $394,000 a year

Qualifications

Research
Pharmaceutical company experience
Leading team collaboration initiatives
Project leadership
Senior leadership

Full Job Description

(Senior) Patient Safety Physician has responsibility for the pharmacovigilance risk management activities of marketed and/or investigational compounds on a global level. In additional to reporting to US line management, this position may matrix reports to a Lead Patient Safety physician. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

Duties & Responsibilities

Develop or support proactive risk management strategies for assigned key marketed and/or investigational compounds.
Plan, manage / perform and monitor all pharmacovigilance activities for assigned drug responsibilities, including:
Chair or support the BI-internal Asset Benefit Risk Team, consisting of experts in Pharmacovigilance, Medical Affairs, Epidemiology and Biostatistics and other disciplines as appropriate
Depending on the status of development of the compound, may be required to lead, manage and medical-scientifically direct a team of risk management physicians responsible for an investigational compound or product including project-specific training and coaching of team members, review of team output.
Provide updates of the assigned drug´s safety profile to senior management and recommend pharmacovigilance / risk management activities to BI decision making bodies and the EU QPPV.
Represent PSPV in internal and external committees & bodies.
Contribute to the further development of pharmacovigilance within BI by staying abreast of state of the art methodology, changes in the regulatory environment and developments and trends in healthcare system and society
Contribute to strategic projects within PSPV (e.g. future software solutions, strategic initiatives, addressing changing global regulatory environment).
In addition to global responsibilities, may represent PV at US-specific cross-functional meetings that require Patient Safety support. May serve as liaison from team to VP, PSPV-US and provide regular updates to US teams and leadership as needed.
Represent PSPV during global health authority interactions.

Requirements

US MD or DO degree or international equivalent from an accredited institution required.
- In addition, the following are strongly preferred:
  - Completion of a US residency or ex-US equivalent.
  - Active or inactive US license to practice medicine, or international equivalent.
- Board certification / experience in a medicine subspecialty would be an asset.
- People leadership potential required.
Senior Associate Director:
- Total applicable experience (incl. clinical practice, plus research or relevant industry) of greater than three (3) years required.
Director:
- Total applicable experience (incl. clinical practice, research or relevant industry) of greater than five (5) years, and a minimum of two (2) years of experience in the pharmaceutical industry or equivalent (preferably pharmacovigilance) required.
- One to three (1-3) years of leadership experience (e.g. projects, teams, initiative) and influencing teams required.
Additional:
- Excellent interpersonal and communication skills (both written and oral) required.
- Ability to attend key meetings in person required.
- Highly ethical personality putting patient safety first.
- Self-starter and driving personality, willingness to take on responsibilities.
- Sound medical-scientific and clinical knowledge and judgement.
- Ability to synthesize large amounts of medical data, draw medical conclusions, and clearly communicate the conclusions.
- Good understanding (based on experience) of Pharmacovigilance and Risk Management in a major pharmaceutical company on a global / corporate level, including safety in clinical development and post-marketing safety.
- Understanding of pharmacovigilance regulation in major markets and respective need for compliance.

Compensation

The Director position offers a base salary typically between $280,000 and $441,000.

The Senior Associate Director position offers a base salary typically between $250,000 and $394,000.

The Associate Director position offers a base salary typically between $200,000 and $316,000.

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regulatory affairs jobs in fishkill, ny

(Senior) Patient Safety Physician, Medical Safety Physician - CRM

Lead Patient Safety Physician - CRM

(Senior) Patient Safety Physician, Medical Safety Physician - Oncology

Senior Associate Director, Medical Affairs Strategy Team Member - Respiratory (Hybrid)

Senior Associate Director, Medical Affairs Strategy Team Member - Pulmonary ILD (Hybrid)

AD / Senior AD, Clinical Pharmacology Lead - Remote

Director, Regulatory Affairs – CMC

Vice President of Compliance

Senior Manager/Associate Director, Regulatory CMC Consultant (REMOTE)

Senior Medical Science Liaison (Nephrology) - Lower Manhattan, Brooklyn, Staten Island, Long Island

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