Director, Regulatory Affairs
Our client is a specialty pharmaceutical company. They have asked us to assist them in their search for a Director, Regulatory Affairs.
Major tasks and responsibilities will include:
We seek candidates with the following qualifications:
- Manages the maintenance of FDA approvals (NDAs, BLAs etc) in compliance with relevant regulatory legislation and guidelines.
- Provides regulatory input into plans for marketed products in line with commercial and company strategy, consulting with appropriate departments where necessary.
- Acts as primary reviewer of all advertising, promotions, and other related materials for assigned products to ensure compliance with applicable FDA laws, regulations and guidance.
- Represents regulatory affairs at project team and LMR team meetings.
- Manages and approves (and distributes as appropriate) core regulatory documents such as Prescribing Information.
- Stays abreast of all relevant regulatory and industry changes and updates related to FDA guidance, warning letters, enforcement actions and regulations and communicates to appropriate internal and external personnel in a timely manner, highlighting the implications of the changes.
- Manages the preparation, attendance and follow-up of meetings with Regulatory Agencies, including the generation of briefing documents and minutes.
- Provides support for regulatory activities associated with due diligence and development strategy for in- and out-licensing activities, as needed.
- Ensures that new safety information received is acted upon, as appropriate, in a timely manner.
- Identifies, retains and manages external experts associated with regulatory activities, as needed.
- Provides regulatory support for medical, and/or marketing/sales initiatives and programs.
- Supervises the review and sign-off on all labeling for marketed products prior to use for assigned products/projects.
- Acts as primary contact with FDA and EMEA for the company. Manages relationships with regulatory representatives for ROW filings.
- Ensures the maintenance of paper and electronic records of all submissions and communications with regulatory authorities, and any supporting documentation.
- Ensures all essential regulatory processes are written, incorporated into and controlled by the company Quality Assurance system.
- Ensures that contracts with third-party Service Providers for regulatory activities include appropriate delegation of responsibilities and deliverables and are monitored for compliance with company core policies and SOPs.
- Performs regulatory assessment of any proposed change under company Change Control system for impact on registered details for products. Provide approval where appropriate.
- Requires life science qualifications with a minimum of 5 years of experience in regulatory affairs in the pharmaceutical industry.
- Expert regulatory knowledge with specific experience in promotional material review is required.
- Must have prior experience of directly communication with the FDA.
- Excellent negotiation, verbal and written communication and interpersonal skills are required.
- Must have good analytical and problem-solving skills
- Requires good organizational and project management skills and attention to detail.
- Ability to understand and present complex scientific arguments is required.
- Must have the ability to decide the final content of regulatory submissions to FDA, ensuring an internal QC check prior to submission, liaising with the Head of Regulatory Affairs where necessary and /or appropriate Regulatory staff in HQ.
- Ability to approve regulatory content of product packaging artwork is required.
- Experience with EMEA and other global regulatory bodies is preferred.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms.