Position: Vice President of Regulatory Affairs and Quality Assurance
Position Summary: Direct, manage and coordinate all Regulatory Affairs and Quality Assurance activities for the Pharmaceutical Division. Interact with regulatory authorities and outside consultants or attorneys as needed. Direct and/or manage QA, QC, and provide assistance for manufacturing operations or contractors. Assist in the general operational management of the firm as requested or directed. This position reports to the President and Chief Executive Officer.
Essential Functions:
1. Provide regulatory strategy for all development programs.
2. Direct clinical, pre-clinical, and CMC regulatory and quality assurance activities.
3. Hire, staff and manage all regulatory and quality assurance personnel to achieve efficiency and meet corporate requirements.
4. Be proactive to minimize or eliminate regulatory issues to help prevent any impact of adverse regulatory activities on the corporate reputation, market, or bottom line.
5. Advise management regarding corporate compliance when the company begins product marketing.
6. Work with marketing to develop the target product profile.
7. Interact with clinical product managers and management on regulatory issues.
8. Stay abreast of regulations and other issues that affect corporate products and discuss bring them to the attention of relevant staff within the firm.
9. Direct outside consultants and contractors as needed for projects in scope of responsibility.
10. Interact with FDA and other regulatory agencies to answer questions, plan meetings, obtain information, and otherwise facilitate regulatory interactions. Serve as the company's most responsible contact for any necessary interactions with regulatory authorities.
11. Interact with foreign regulatory authorities in the same capacity, as necessary.
12. Review all critical correspondence to and from regulatory authorities.
13. Be responsible for all regulatory dossiers submitted.
14. Manage budgets for Regulatory Affairs and Quality Assurance to meet corporate needs.
15. Other duties as required or requested.
Knowledge, Skills and Abilities Required:
1. Excellent written and oral communication skills; ability to communicate effectively and project a professional image when giving and taking information in writing, in person, and over the phone.
2. Display of confidence and calmness during FDA interactions.
3. A good understanding of the processes involved in early stage research, preclinical development, clinical research, process development, manufacturing, quality assurance and quality control, and marketing.
4. Good interpersonal skills and ability to lead and work with co-workers and outside agencies professionally and tactfully.
5. Ability to take initiative and prioritize tasks; good time-management, problem-prevention, and problem-solving skills.
6. Ability to independently exercise judgment in developing methods and criteria for determining appropriate action to obtain objectives.
7. Strong analytical ability with active listening skills.
8. Ability to work accurately with close attention to detail.
9. Ability to maintain confidentiality of sensitive information.
10. Experience with electronic regulatory submissions.
Qualifications:
1. Minimum of 10 years in a responsible regulatory affairs management positions within the pharmaceutical or biotechnology industry, good computer skills, and evidence of accomplishments in regulatory affairs.
2. Familiarity with biologic drug development.
3. Ability to manage staff on-site and remote employees.
Education:
Bachelors of Science degree required. Doctoral degree desired.
Contact:
Send resume to jobs@biothera.com. No calls please.