Manager, Regulatory Operations

The Manager, Regulatory Operations leads Regulatory Operations activities and strategic initiatives in support of clinical programs as well as commercial filing efforts. The position requires the ability to manage regulatory operations services from filing and maintenance of investigational new drug (IND) submissions to the FDA, filing of marketing applications for new products in regulated markets, to preparation for regulatory agency meetings. The Manager of Regulatory Operations will be a key member of matrixed project teams, will maintain submission-planning timelines for assigned submissions, develop and implement submission strategies, and archive regulatory submissions and correspondence.

Responsibilities:

• Plan and manage the operational aspects of submissions to regulatory agencies such as investigational new drug applications (IND), Clinical Trial Applications (CTA), and all documents provided therein (Quality Overall Summary/IMPD/Clinical Protocol/Investigator's Brochure), as well as new drug applications (NDA/MAA)
• Prepare submission content plans and establish/manage timelines for all regulatory submissions
• Familiarity with formatting and publishing of documents in eCTD format
• Act as lead representative for interactions with regulatory publishing vendors
• Participate as an active member of multi-disciplinary teams, ensuring appropriate and effective communication to facilitate submissions in support of both early and late-stage clinical development programs
• Lead and manage IND maintenance activities such as annual reports, expedited safety reports, investigator information updates, and nonclinical/clinical study reports as needed
• Manage registration and maintenance of clinical trials on clinicaltrials.gov in collaboration with cross-functional team members
• May also manage, in close collaboration with cross-functional teams, the generation of regulatory submission content
• Support global commercial filing efforts and post-approval submissions activities
• Assist in the development and maintenance of company-wide, and departmental processes, policies, SOPs and associated documents
• Participate in initiatives aimed at improving internal standards and systems
• Help keep cross-functional team members apprised of new regulations, standards, policies, and guidance issued by regulatory authorities that may impact the company

Requirements

• Bachelor's degree, scientific field preferred
• 5 years prior experience within the biotech / pharmaceutical industry, including 3 years in a Regulatory Affairs/Regulatory Operations group
• Advanced technical skills for regulatory document preparation, publishing, and submission, including life cycle management
• Expertise in eCTD format and regulatory submission requirements
• Proficiency with MS-Office Suite and Adobe Acrobat
• Experience in implementation of and effective utilization of Veeva RIM system, including development of SOPs and training programs
• Experience leading the management of submissions/timelines and collaborating with team members
• Working knowledge of FDA Regulations
• Previous experience developing work instructions and generating SOPs that are consistent with global regulatory requirements and company business practices
• Ability to manage, streamline, and collaborate to improve document preparation and management systems
• Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company
• Highly accountable for the results and outcomes of their responsibilities and understands the impact of their efforts, results, and attitudes on others
• Uses teamwork to work cooperatively toward the most effective solutions, championing the best ideas of team members, and assisting where help is needed yet is capable of highly independent work when efficiency is required

The starting base pay range for this position is $106,056.00 - $137,593.00. Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee's geographic location.

Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and immediate vesting
• Flexible time off
• Generous parental leave and some fun fringe perks!