Job Description
Our client, a leading pharmaceutical company, is currently recruiting a Director of Regulatory Affairs who will infuse the Regulatory Affairs Team with their talent, energy and leadership skills. This is an exceptional opportunity to join a corporate culture that is known for its innovative and growth-oriented vision. Responsibilities include:
1) Provide regulatory due diligence and regulatory advice
2) Develop regulatory strategies
3) Oversee and direct external vendors providing services related to regulatory submissions
4) Review CRO capabilities particularly evaluating regulatory competency and capacity to support international submissions
5) Ensure effective department procedures, including creating and reviewing SOPs as needed
6) Coordinate interactions with regulatory authorities and effectively engage with regulatory agencies worldwide
7) Lead the preparation of submissions, which may include INDs, briefing documents and marketing authorization applications
8) Work with cross-functional teams to define contributions to submissions and then lead regulatory submission teams
9) Maintain up-to-date knowledge on current US Regulatory requirements and ICH guidelines
10) Provide interpretive analyses regarding impact of regulatory guidance documents, regulations and directives that impact company products and operations
11) Identify external vendors with capabilities to support regulatory filings
12) Provide regulatory input to project teams for clinical development, CMC and post-marketing drug and device filings
13) Develop resource plans for company regulatory submission projects
14) Prepare high quality submissions of annual reports, supplements and amendments
15) Review submissions for accuracy and verification of pre-clinical, clinical and nonclinical data
16) Facilitate timely regulatory approvals by ensuring the quality and appropriateness of submission documents
17) Ensure timelines for submissions and reports are identified and met
Critical Requirements
1) A university degree is required. Although all candidates are welcome and encouraged to apply, preference will be given to those with degrees in a relevant field
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the pharmaceutical industry is strongly preferred
4) Preference will be given to candidates with recent experience in regulatory affairs management
For the right leader, this is a wonderfully rewarding role with tremendous growth prospects. If you are qualified and think you're a strong fit for this role, please apply ASAP. We thank all applicants, but only candidates who meet our client's criteria will be contacted.
Compensation and Other Details
Base Salary: Highly competitive package, commensurate with experience