About the company
A career at the company offers opportunity, ownership and impact.
All over the world, the company colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. the company, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
The Regulatory Strategist provide leadership in the management of project focused level support and/or managerial oversight of personnel responsible for pre- and post-approval regulatory activities related to assigned PCH products in OTC drug, device, cosmetic, food, dietary supplements and/or Rx to OTC switch in a country or country cluster. This role provides strategic expertise for assigned project(s) and is accountable for leading and implementing regulatory strategies in agreement with key stakeholders and in line with commercial goals. Accountable for timely submissions and approvals with commercially attractive labeling and ensuring optimal regulatory interactions with BOH authorities. Actively supports and participates in building success with commercial and enabling functions. Proactively contributes to regulatory intelligence, insight and influence of regulatory landscape to foster business needs. This role ensures regulatory contributions achieve project objectives and adherence to regulatory and the company standards.
Regulatory Assessment, Strategy & Implementation:
• 5 + years experience in OTC drug/medicines inclusive of working knowledge of NDA and IND fundamentals and FDA engagement.
• Develops and leads the execution of regulatory strategies, in a risk based approach, to optimize regulatory approval, timing, competitive positioning and global opportunities for new and existing products.
• Ensures regulatory contributions achieve the objectives of the strategy in line with agreed standards, maximizing overall project delivery time and probability of success. Facilitates filing activities for new applications and lifecycle management.
• Provides strategic expertise as representative WSR in cross functional project teams.
• Ensures regulatory plans are monitored, progress/variance communicated to key internal/external stakeholders and any risks mitigation plans are prepared.
• Develops and/or oversees regulatory assessment, strategy and implementation activities and overall communication of risk mitigation plan and measures to business partners.
• Coordinates, prepares and files NDAs/major filings, post-approval supplements and lifecycle changes in line with business objectives and timing.
• Builds regulatory content by authoring or redacting core information for submission of components not delivered by other functional areas.
• Ensures timely review/approval of labeling, artwork and promotional materials and adherence to commercial and regulatory standards.
• Interacts with appropriate cross-functional teams to shape label for assigned projects/products to ensure commercial needs and quality standards are met.
• University Bachelor's Science degree; a higher degree may be an advantage but is not essential. Post-secondary Regulatory Affairs Certification an asset.
• Minimum 5-10 years of applied regulatory experience in the pharmaceutical industry, with preferred OTC regulatory experience.
• Proven ability to manage multiple projects in a fast paced environment and exercise good judgment prioritizing tasks.
• Experience in communication with key regulatory authority as well as participating or leading interactions is preferred.
• Experience in regulatory strategy development and submission preparation and filing (within at least one therapeutic area throughout the product lifecycle, preferred).
• Regulatory Experience with Consumer products required; additional experience in Rx Regulatory Affairs may be advantageous.
• Proven ability to manage complex regulatory issues.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS:
Standard work schedule; travel as needed
Other Information - Internal
Colleagues who are issued an Incident Final Warning (IFW) on or after January 1, 2016, are not eligible to post and compete for a position for a period of 12-months from the date an IFW is issued.
EEO & Employment Eligibility
the company is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. the company also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. the company is an E-Verify employer.
A little about us:
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