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JOBS - Regulatory Affairs
There are currently 7 jobs listed in this category (displaying 1 to 3).
Associate Director, Global Regulatory Strategy
Location: New Jersey
Job Description
- Provides guidance to, and shapes the direction of internal groups (e.g., Regulatory Team, Multi-functional Development team, strategy teams) based on a solid understanding of the disease, science, company's strategic perspective, and regulations.
- Lead global regulatory teams and represent Global Regulatory Science on project teams. Manages the strategy and execution of interactions with the FDA.
- Establishes close working relationships with [company] global liaisons and collaborates in strategic meetings with non-US health authorities
- Provides ongoing feedback, coaching, and career development support to staff in order to maximize their full potential.
- Delivers effective, persuasive presentations to regulatory authorities and creates clear and concise documents regarding regulatory strategy for senior management.
- Interfaces with leaders in Global Regulatory Science and senior management in [company] operating committees to communicate and propose approaches to resolving important issues.
Job Requirements
- MD or PhD or other advanced life science degree with equivalent experience
- 5-10 years in pharmaceutical experience within regulatory environment
- Strong application and working knowledge of the drug development process
Contact Information
Karen Baldwin
kbaldwin@criticalpathinc.net
(412)851-4144 x: 15
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Associate Director, Regulatory Strategy
Location: New Jersey or Connecticut
Job Description
Manages the preparation for the FDA meetings and provides strategic guidance on the organization of these meetings. Interfaces with the FDA review team as appropriate. Assists in preparing global regulatory perspective into development plans. Assimilates input from global regulatory liaisons and generates regulatory plans which reflect global perspectives. Incorporates the culture and regulatory differences of global markets in the development of strategy. Shapes the content of regulatory dossiers by considering the scientific and regulatory perspective that will be most effective in obtaining a successful filing. Anticipates potential registrational issues and develops strategies to address and quickly resolve problems.
Job Requirements
MD, PhD or other advanced life sciences degree with equivilent experience. 3-5 years pharmaceutical industry experience within a regulatory environment. Strong application and working knowledge of the drug development process. Mastery of the science in endocrinology or metabolic diseases area and its impact on the regulatory process. Proactive interaction with regulatory agencies both US and global. Ability to responsd the questions from regulatory agencies.
Contact Information
To respond to this job please contact:
Karen Baldwin
kbaldwin@criticalpathinc.net
412-851-4144 x 12
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Director, CMC
Location: New Jersey (central)
Job Description
Our client, a global leader in pharmaceutical research and development currently has 2 openings in their CMC regulatory department. A background in either CNS or Oncology/Biologics is required.
The successful candidate will be resoponsible for for the global CMC regulatory strategy for a specific therapeutic area and manage one or more regulatory professionals. In addition to managing personnel, this position entails participation on various cross functional teams, interaction with key partners both internal and external to the company, responsibility for compilation and response for regulatory submissions including IND, CTA, NDA, MAA, BLA, supplemental applications and maintenance dossiers. Project responsibilities will range from early development through life cycle maintenance of marketed products. This position interacts directly with the FDA and other health authorities.
Job Requirements
10 years in the pharmaceutical industry with at least 6 years in CMC regulatory strategy. Experience developing regulatory strategies and handling health authority questioned responses. Experience must include strategy responsibility for late stage development of a large molecule leading to approval.
Contact Information
To respond to this job please contact:
Karen Baldwin
kbaldwin@criticalpathinc.net
412-851-4144 x 12
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