What are the responsibilities and job description for the Global Regulatory Lead position at Jobleads-US?
About Jobleads-US
We are seeking a highly skilled Regulatory Affairs Manager to join our team. The successful candidate will be responsible for providing strategic and operational guidance on regulatory matters, working closely with the RA GPT representative and/or Global Therapeutic Area Lead (GTAL).
Responsibilities:
- Regulatory Strategy
Determine the requirements for regulatory plans and ensure their execution in line with global regulatory strategy.
- Lead planning, preparation, and submission of clinical trials.
- Implement defined global registration strategies into regional submissions worldwide by country organizations.
- Coordinate, plan, and prepare for submission of initial registrations and post-approval applications, and the preparation, review, and maintenance of local product information as assigned.
Essential Requirements:
- Science-based BS or MS degree with requisite experience and demonstrated capability; Advanced degree (MD, PhD, PharmD) preferred.
- Background in a global/matrix environment or cross-functional teams in the pharmaceutical industry.
- Experience with regulatory submission and approval processes in 1 or more major regions.
- Expertise in HA negotiations.
- 2-4 years involvement in regulatory and drug/biologic development spanning activities in Phases I-IV, focusing on areas like innovation in regulatory strategy, post-marketing/brand optimization strategies, commercial awareness, dossier submissions and approvals, HA negotiations, drug regulatory submission and commercialization in region, analysis and interpretation of efficacy and safety data, regulatory operational expertise, strong interpersonal, communication, negotiation and problem-solving skills.
