Head of Global Regulatory Affairs
Job creation – Permanent contract – Full time position
Based in Burlington, Massachusetts, USA
Reporting to the EVP, Clinical & Regulatory Affairs, you will be accountable for supporting the development and registration of the company’s products in the US, the EU, and Japan. You will ensure that programs are resourced with appropriate regulatory expertise to successfully implement regulatory strategies and business objectives. You will also lead development and implementation of department policies as well as maintain awareness of the global regulatory environment and assess and communicate impact of changes on business and product development programs.
Your main responsibilities are:
- Developing, leveraging, and implementing innovative and strategic thinking to lead Poxel’s regulatory strategies in order to accelerate the progress of preclinical programs, clinical programs and commercial launches;
- Overseeing the planning and execution of meetings with health authorities, in particular in the US, EU and Japan;
- Overseeing preparation and submission of global regulatory filings, including clinical trial authorization (e.g., IND, CTX) and marketing (e.g., NDA, MAA, IDL) applications as well as timely completion of routine regulatory submissions required for maintenance of applications, such as expedited and aggregate safety reporting (e.g, PADERs, DSURs, etc.), and annual reports in Japan;
- Overseeing or providing regulatory due diligence assessments of new product opportunities;
- Keeping abreast of changes in the regulatory environment and adapting strategies appropriately;
- Supporting global preclinical and clinical studies with expert knowledge in drug development requirements and standards for clinical trials;
- Developing, leading, and managing a regulatory function that complies with appropriate regulations and guidelines and demonstrates operational efficiency;
- Creating effective team resource plans, structures and processes and instituting appropriate SOPs;
- Interacting with senior level regulatory counterparts at partner companies, contract manufacturers and regulatory agencies in Japan as well as the US and the EU;
- Ensuring all interactions with agency personnel (US and Ex-US) are conducted to the highest degree of professionalism;
- Overseeing regulatory review of external facing communications, including corporate communications, and investor relations;
- Ensuring professional development of staff;
- Overseeing development of timelines and budgets for department activities;
- Creating, modifying, and implementing regulatory infrastructure that enables the company to operate effectively and efficiently and support cross-functional communications and interactions.
You have a B.S. degree in a healthcare- or life sciences-related field, and ideally an advanced degree (e.g., M.S., Ph.D., Pharm.D., M.D.).
You possess a minimum of fifteen years of experience in regulatory affairs, with at least five years in a senior leadership capacity within the context of a biopharmaceutical company. Preferably some of this experience would have occurred in small- to mid-sized company. You ideally have experience in metabolic diseases and across multiple therapeutic areas. You have also experience developing innovative, complex global regulatory strategies for filings from early development (pre-IND/CTA) through to approval (NDA/BLA/MAA) and leading interactions with the health authorities. Experience with a 505(b)(2) filing would be a plus.
You are a trustworthy person, dedicated and operate with strong independent judgement. You are decisive, self-motivated and highly communicative.
You also have strong strategic skills, including a demonstrated ability to make complex decisions and a willingness to defend difficult positions. You are a strong leader who possesses a proven track record in leading an organization through change and rapid growth and ensuring the appropriate capabilities are in place to support such growth. Effective management, negotiation, and problem-solving skills are necessary. It is also paramount that the Head of Global Regulatory Affairs have unquestionable integrity and the highest ethical standards.
As part of our disability inclusion action plan, our company's hiring policy aims to improve the representation of employees with disabilities in its workforce.
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