1) Provide strategic and operational leadership in the area of advertising and promotion, primarily pertaining to US marketing activities and products within the therapeutic areas of Cardio-Pulmonary and Hepatitis B under the direction of the Associate Director of Regulatory Affairs
2) Review promotional materials for compliance with the promotional regulations and guidance documents
3) Represent the regulatory perspective at Promotional Review Committee (PRC) which includes cross functional partners from Marketing, Medical Affairs and Legal
4) Serve as the company's regulatory liaison to the FDA Division of Drug Marketing, Advertising and Communications (DDMAC) for respective products and ensure materials are submitted to FDA in a timely manner
5) Review and approve promotional materials for company marketed products
6) Characterize the regulatory promotional perspective and rationale at regulatory project team meetings and brand team meetings and provide training to Product Manager counterparts in marketing and members of the PRC
7) Review enforcement letters, keep current with industry changes related to advertising and promotion, interpret new guidance to industry and evaluate processes within regulatory affairs
8) Prepare /oversee the preparation of technically complex regulatory submissions which require extensive interaction with departments outside of Regulatory Affairs for investigational and commercial products for assigned territories in line with ICH requirements, regional requirements and scientific and company policies and procedures
9) Direct others in accomplishing corporate objectives
10) Submit complex regulatory documents, including safety reports, amendments, supplements and license renewals to clinical trial applications and marketing authorizations original INDs/CTAs and NDAs/MAAs for assigned territories
11) Prepare the Company Core Data Sheets (CCDS) for assigned products
12) Contribute to the regulatory review of draft Product Company Core Safety Information (CCSI) and ensure updates to the CCDS or CCSI are implemented
13) Ensure product packaging and associated information are updated and maintained in accordance with the product license
14) Provide strategic regulatory advice as appropriate
15) Maintain knowledge of regulatory requirements and communicate changes in regulatory information to project teams and senior management in a timely manner
16) Initiate local process improvements and contribute to local and global process improvements, which have a significant impact for the regulatory affairs department or other departments
17) Plan, schedule and arrange own activities and those of direct report (if applicable)
More questions? Want to know the Salary range? Keep reading.
The best way to get more details is to click ‘Apply’, upload your resume, and ENTER YOUR QUESTIONS in the ‘Cover Letter’ field. A recruiter will call you and answer all of your questions (if they feel you are a fit for the role). Your resume will be kept CONFIDENTIAL – we respect your privacy. Our Recruiters are more likely to respond to your questions if they know you are *seriously* interested, and prefer to know a little bit about your background before calling.
1) Follow our CEO on Twitter for status-updates about your job application:http://www.twitter.com/sterlinghoffman
2) Add our CEO on Facebook:
We will try to respond to your questions privately via Twitter or Facebook only.
TAGS: Biotechnology Jobs, Pharmaceutical Jobs, Medical Device Jobs, Small Molecule, Biologic, Oncology, Hematology, Dermatology, Neurology, Cardiology, Urology, Nephrology, Vaccine, Disease, Drug Development, Surgery, Physician, EMR, Healthcare, Life Sciences, Scientist, R&D, Clinical Research, Clinical Trial, Regulatory Affairs, Nutraceutical, Surgeon, MD, Hospital, Immunology, Quality, QC, Validation, Engineer, QA, Manufacturing, Engineering, Aseptic, Sterility, Hospital, Research and Development, Medical Affairs, Drug Safety
1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply)
2) Appropriate full-time work experience is mandatory (no students or fresh graduates please)
3) Recent experience in the biopharmaceutical industry is strongly preferred
4) Preference will be given to people who have recent experience in Regulatory Affairs Management
Sterling-Hoffman Life Sciences is the premier recruitment firm in North America for companies involved in the research, clinical development, manufacturing and distribution of drugs and devices that allow patients to live healthier and more fulfilling lives. Leveraging a network of relationships in every major city – including New York, San Francisco, Raleigh-Durham, Chicago, Dallas, Denver and Los Angeles – Sterling-Hoffman Life Sciences is ideally positioned to assist fast growing CROs, pharmaceutical companies, biotech firms and medical device players in their quest to recruit the best people.