Manager / Senior Manager, Regulatory Affairs

About the Role

We are seeking a highly skilled, and experienced Manager / Senior Manager, Regulatory Affairs to join our growing clinical team. This hands-on position will be responsible for overseeing and managing all global regulatory activities to ensure compliance with applicable laws, regulations, and guidelines. As Manager / Senior Manager, Regulatory Affairs, you will play a crucial role in effectively operationalizing regulatory strategies, managing regulatory projects, providing leadership, and guiding our company through complex regulatory landscapes. The successful candidate will have experience, and interest in, working in a small, dynamic environment with broad responsibilities.

Key Responsibilities 

• Collaborate cross-functionally with internal teams, including clinical, clinical operations, quality assurance, pharmacovigilance, and non-clinical, to prepare, review, and submit high-quality regulatory submissions, including INDs, NDAs, BLAs, and other relevant applications, ensuring compliance with regulatory requirements and timelines.
• Final accountability for regulatory documentation, ensuring adherence to FDA and other health authority specifications and timelines, including submissions, correspondence, approvals, and ensuring accurate and organized records.
• Manage third party vendor partner performance and workload to support regulatory operations and regulatory publishing.
• Provide project management support for regulatory projects, including defining project objectives, developing project plans, allocating resources, and monitoring progress to ensure timely completion.
• Serve as a primary contact and maintain and foster effective relationships with regulatory experts, such as the FDA, EMA, and other regulatory agencies, ensuring open communication.
• Develop and implement standard operating procedures (SOPs), best practices, and quality control measures to ensure compliance with regulatory standards.
• Utilize project management tools and methodologies to effectively plan, track, and report on regulatory project status, milestones, and risks.
• Stay updated on evolving regulatory requirements, guidelines, and industry trends to proactively identify potential risks, opportunities, and impact on the organization.
• Manage regulatory budgets, resources, and timelines to optimize operational efficiency and meet business objectives.

Qualifications and Skills

• Bachelor's degree in life sciences, pharmacy, or a related field with a minimum of 5 years of experience in oncology regulatory affairs within the biopharmaceutical industry.
• Experience with global regulatory requirements and guidelines (including FDA, EMA, IHC), from preclinical, and clinical stages. Expertise and knowledge of drug laws, regulations, guidelines, and lifecycle management.
• Excellent communication, and interpersonal skills with the ability to collaborate effectively with internal teams, external partners, and regulatory authorities.
• Experience in managing regulatory inspections, audits, and interactions with regulatory agencies including direct contact with regulatory agencies.
• Experience with executing regulatory strategies for complex products or therapies, including regulatory interactions, submissions, filings, and approvals.
• Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory concepts to diverse audiences.
• Detail-oriented with excellent organizational and project management skills, capable of managing multiple projects and priorities simultaneously in a fast-paced environment.

Recruitment fraud statement

Please be aware of recruitment fraud and related job scams, where scammers present themselves as recruiters but are seeking to steal money or personal information. Keep the following in mind to protect yourself:

• Treeline Biosciences will never ask for money from you as part of our recruitment process. Do not provide bank details or pay somebody for the promise of a job at Treeline.
• We do not conduct interviews through Skype or Telegram.
• Our job openings are first posted to treeline.bio/careers. If you locate a listing for a Treeline job on another site, please ensure it is also posted on our careers website.
• You can find more information about job scams at consumer.ftc.gov/articles/job-scams.
• To report job scams, head to ReportFraud.ftc.gov.

Notice to Search Firms/Third-Party Recruitment Agencies (Recruiters)

The Human Resources team manages the recruitment and employment process for Treeline Biosciences. To protect the interests of all parties involved, Treeline Biosciences will only accept resumes from a recruiter if an executed search agreement directed to the particular position or positions is in place at the start of the recruitment effort. Unsolicited resumes sent to Treeline Biosciences from recruiters do not constitute any type of relationship between the recruiter and Treeline Biosciences and do not obligate Treeline Biosciences in any way to pay fees should we hire from those resumes. Recruiters are requested not to contact or present candidates directly to our hiring manager or employees.