Boehringer Ingelheim Pharmaceuticals, Inc

Manager, RA Pharma Safety & Efficacy

Boehringer Ingelheim Pharmaceuticals, Inc • $110K — $130K *
Athens, GA 30606In-Person
Pharmaceuticals & Biotech
Less than 5 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Advanced degree (DVM or PhD) with 2+ years in Regulatory Affairs or similar pharma experience OR Master's in relevant scientific discipline with 7+ years in Regulatory Affairs.
  • Excellent command of English, both written and spoken.
  • Demonstrated experience in Regulatory Affairs or equivalent in the pharmaceutical industry.
  • Ability to collaborate globally and manage multiple projects with a full workload.
  • Strong communication, negotiation, and interpersonal skills.

Responsibilities

  • Oversee safety and efficacy documentation for new veterinary products and lifecycle management for assigned products.
  • Coordinate technical inputs for Freedom of Information Summary and product labeling.
  • Act as a regulatory affairs sub team member within project teams to achieve Target Product Profile objectives.
  • Provide regulatory advice on approval pathways, focusing on time to market, costs, and marketability.
  • Represent the company at external functions to advocate for company interests.
  • Contribute to regulatory assessments during due diligence processes.
  • Evaluate product dossiers for regulatory compliance prior to registration.

Benefits

  • Participation in external functions and industry meetings to enhance professional network.
  • Involvement in diverse global projects within a collaborative team environment.
  • Opportunity to drive change while supporting regulatory compliance.
  • Access to developmental resources and regulatory tools for best practices in the field.
Full Job Description
Description

The Manager, RA Pharma Safety & Efficacy will represent the US regulatory safety and efficacy function in global development projects and provide regulatory strategy for assigned projects that leads to a reliable and efficient timeline for product approval. The expectation of the position holder will be to understand pertinent regulations and guidance and ensure the project team meets US requirements in development activities. The manager will be responsible for FDA meetings and submissions for their assigned projects. This role is responsible for linking regulatory affairs information to internal and external stakeholders (FDA) to ensure sufficient and efficient communication through activities such as governance review, project team meetings, planning activities and FDA communications.

Duties & Responsibilities

  • Responsible for the safety and efficacy part of the dossier for new veterinary products as well as life-cycle management of existing products for assigned projects/products in US and other markets, when applicable.
  • Responsible for coordinating technical input for Freedom of Information Summary and product labeling for assigned projects.
  • Works in project teams as an RA sub team member in accordance with the project governance model to drive Target Product Profile objectives.
  • Provides consistent regulatory advice to project teams regarding the pathways and approaches to regulatory approvals with details pertaining to time to market, costs, and robustness/marketability of each approval.
  • Represents company at external functions, such as trade association meetings, to support BI interests.
  • Participates in due diligence processes by providing input into the regulatory assessment.
  • Participates in the evaluation of the product dossiers for regulatory compliance and suitability for registration.
  • Represents RA for infrastructural processes and projects.
  • Responsible for the successful update of regulatory tools as defined.
  • Supports specific infrastructural projects as assigned.


Requirements

  • Advanced degree (Doctor of Veterinary Medicine or PhD in relevant discipline) with minimum two (2) years related experience in Regulatory Affairs or equivalent/relevant experience in the pharmaceutical industry.

OR
  • Masters in relevant scientific discipline with minimum seven (7) years related experience in Regulatory Affairs or equivalent/relevant experience in the pharmaceutical industry.
  • Excellent command of English language, both written and spoken.
  • Regulatory Affairs or equivalent pharma industry experience is required.
  • Intrapreneurial spirit while being rigorous and disciplined with compliance requirements.
  • Ability to collaborate in a global organization and manage a full workload across multiple projects.
  • Effective communicator with good negotiation and interpersonal skills and the ability to form productive working relationships.
  • Able to meet stringent time and quality demands.
  • Strong team player who is collaborative with the mission of BI, but able to drive change.
  • Ability to handle high workloads and understanding of cultural differences.
  • Well-developed organizational capabilities.
  • Self-motivated.


Eligibility Requirements :
  • Must be legally authorized to work in the United States without restriction.
  • Must be willing to take a drug test and post-offer physical (if required).
  • Must be 18 years of age or older.

About Boehringer Ingelheim Pharmaceuticals, Inc

Boehringer Ingelheim Pharmaceuticals, Inc. is a research-driven pharmaceutical company that discovers, develops, and manufactures prescription medicines. The company's mission is to improve the health and quality of life of patients by developing innovative therapies. Boehringer Ingelheim Pharmaceuticals, Inc. is a subsidiary of Boehringer Ingelheim Corporation, which is headquartered in Ingelheim, Germany. The company's research and development efforts focus on respiratory diseases, immunology, oncology, and diseases of the central nervous system. Boehringer Ingelheim Pharmaceuticals, Inc. was founded in 1885 and is based in Ridgefield, Connecticut.
Learn more about Boehringer Ingelheim Pharmaceuticals, Inc
Size
5,000 employees
Industry
Pharmaceuticals & Biotech
* Ladders Estimates

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