Job Description
DESCRIPTION
- The mission of the client is to develop innovative global registration strategies that advance their pipeline products through approval in US and EU
- In this position, the Regulatory Affairs Scientist-Strategy (Sr Manager to Director) will lead execute strategy and tactics for the global development team, and support the Head of Regulatory Affairs in the development of sound global regulatory registration strategies
- Execute Regulatory strategy, guidance, document management, and regulatory intelligence for small molecules and biologics in US and EU.
MAJOR RESPONSIBILITIES AND DUTIES
- Prepare and execute Regulatory filings for IND/CTA/NDA/MAA/PSP, briefing books, and responses to health authority inquiries;
- Develop submissions and filings in partnership with CMO, head of Regulatory Affairs, and external collaborators;
- Liason with US FDA, EU and other regulatory authorities as assigned;
- Coordinate with teams within HMPL and CRO partners to address any questions from health authorities in the US and EU;
- Coordinate authoring, review and QC of regulatory documents provided by clinical, pharm/tox, or research and development;
- Ensure compilation of electronic submissions according to current health authority standards;
- Provide regulatory oversight by developing and implementing SOP's;
- Acquires and maintains thorough current knowledge of regulatory requirements; stays abreast of developing regulatory changes affecting products/projects
Additional Skills & Qualifications:
- BS degree in health related field, e.g. Biology, Pharmacy, Clinical pharmacology or public health and 5 years industry or relevant experience, OR Advanced degree, e.g. PhD, PharmD and 2 years industry experience
- Experience with US and EU CMC filings, INDs, NDAs, BLAs, sBLAs and product approvals
- NDA or BLA filing experience a plus
- Thorough scientific knowledge, understanding of regulatory policy, GCP, and ICH guidelines
- Good leadership, organization, problem-solving & communication skills
- Excellent written and oral communication skills
- Sensitivity for multicultural/multinational environment and understanding of global pharmaceutical development process
- Proficiency on key operations systems, including eCTD submissions software and electronic gateway submissions, a plus
- Familiarity with infrastructure software, such as EDMS/RIMS/eCTD a plus
- Knowledge of EU regulatory regulations a plus
- Ability to manage priorities and workflow, managing multiple projects and meeting deadlines
- Acute attention to detail
- Good judgement with the ability to make timely and sound decisions
Skills:
- Regulatory affairs, Strategy, Fda, Regulatory, Nda, Regulatory submission, Cmc, Compliance, Oncology, Pharmaceutical
Top Skills Details:
- regulatory affairs, regulatory Strategy, FDA submission experience
Experience Level:
Expert Level
About Aerotek:
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
