- Develop and execute US regulatory strategy, with oversight as needed, and in conjunction with Global Regulatory Lead (GRL), Global Regulatory Team and Global project teams.
- Partner with the GRL to understand the competitive landscape, e.g., views of US HAs, regulatory precedents, labeling differences and TA-specific issues.
- Utilize US regulatory expertise and knowledge of regulatory requirements and regulations to interpret, plan, and communicate requirements to deliver target product profile (TPP).
- Ensure successful US regulatory outcomes and monitors progress against strategy and adjusts as needed
- Prioritize US TA regulatory activities based on company objectives ensuring most critical regulatory tasks are of primary focus.
- Serve as the primary contact with FDA Health Authorities (HA).
- Within the context of the global strategy, determine the timing, appropriate US regional strategy and content for all HA meetings.
- Participate in cross-functional teams for interactions with US FDA HA as appropriate.
- Assist with preparing company personnel for interactions with HA.
- Ensure that responses to HA questions are handled in a timely manner and in line with the approved product strategy.
- Communicate regulatory options and strategy to all stakeholders, including within GRA, and cross functionally (e.g. R&D, quality, commercial) to ensure that everyone is aligned to the strategy.
- Provide proactive communication of risks and gaps and mitigation plans.
- Build effective relationships with cross-functional stakeholders within assigned therapeutic area
- Critically evaluate documents to be submitted to regulatory agencies for submission filing to comply with applicable regulations and project objectives.
- Responsible for quality and timeliness, including planning and review of US regulatory submissions (i.e. INDs, NDAs, BLAs meeting requests, briefing documents and supplements) that support US clinical trials and product registrations.
- Assure compliance of development projects and products post approval with regulations and commitments.
- Stay abreast of regulatory changes and developments that may impact the company's products.
- Monitor current and proposed regulatory issues and trends.
- Provide regulatory advice to ad hoc teams/task forces set up for process improvements, alignment with new regulatory requirements or business initiatives on behalf of GRA.
- B.S. in a scientific discipline required. Advanced degree and RAC preferable.
- At least 5 years pharmaceutical/biotech industry experience with at least 3 of those being in US regulatory affairs strategy.
- Experience developing regulatory strategies and an understanding of product development and how it is applied in US regulatory strategy for all types of products (drugs, biologics, devices and combination products).
- Gastroenterology therapeutic area experience desirable
- Proven ability to manage multiple projects, identify and resolve regulatory issues.
- Experience critically reviewing and compiling documents is required.
- Direct experience with US regulatory documents and submissions (IND, NDA, BLA) in eCTD format. Experience with PMA submissions desirable.
- Proven experience in FDA approvals, regulatory interactions/meetings and negotiations.
- A track record of working successfully within a cross functional team environment as an individual contributor.
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Senior Manager, Regulatory Affairs - Parsippany, United States - Ferring Pharmaceuticals Inc.
Description
Job Description:As a privately-owned, biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first' philosophy. Built on a 70-year plus commitment to science and research, Ferring is relentless in its pursuit of science that drives powerful discoveries and therapies to help people build families, stay healthy, and stand up to the world's oldest enemy: disease.
As the Senior Manager, Regulatory Affairs you will be responsible for the development and execution of US regulatory strategy for projects within an assigned Therapeutic Area ("TA"). The Senior Manager will manage FDA regulatory interactions and submissions that support TA development projects and products across Ferring's portfolio. The role is also responsible in maintaining compliance and keeping current with changes in the regulations.
With Ferring, you will be joining a recognized leader, identified as one of "The World's Most Innovative Companies" by Fast Company, and honored by Fortune with inclusion on its "Change the World List," for addressing society's unmet needs. Ferring US is also Great Places to Work Certified, distinguishing it as one of the best companies to work for in the country.
Responsibilities:
US Regulatory TA Strategy
Ferring + you
At Ferring, we offer competitive total compensation along with an exceptional range of flexible benefits, personal support and tailored learning and development opportunities all designed to help you realize your full potential both in life and at work. From working hours that respect your lifestyle, a culture that is welcoming and equitable, and the chance to work with the industry's most impressive people, these are just some of the ways we live our "People First" philosophy.
Our Compensation and Benefits
At Ferring, base salary is one part of our competitive total compensation and benefits package and is determined using a salary range. The base salary range for this role is $103,550 to $188,500, which is the reasonable estimate of the base compensation for this role. The actual amount paid may differ based on non-discriminatory factors such as experience, knowledge, skills, abilities, education and primary work location. Additional compensation for this role will be provided based on competitive annual incentive compensation targets in the form of an annual bonus - payouts are based on individual and company performance.
Benefits for this role include comprehensive healthcare (medical, dental, and vision) with a premium differential, inverse to base salary, to be paid by employees, a 401k plan and company match, short and long-term disability coverage, basic life insurance, wellness benefits, reimbursement for certain tuition expenses, sick time of 1 hour per 30 hours worked, vacation time for full time employees to accrue up to 120 hours in the first four (4) years of employment, and 160 hours in the fifth (5th) year of employment as well as 12 to 13 paid holidays per year. We are proud to offer 26 weeks of paid parental leave, learn more about the parental leave offering in our benefits package here.
Ferring is an equal opportunity employer. All aspects of employment will be based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, state, or local laws.
Join our team and your voice will be heard, and your contributions will be valued. If you love to come up with new ways to make a positive difference and see them through, you will fit right in.
We are proud to be an Affirmative Action/Equal Opportunity Employer (including Disability/Protected Veterans). We maintain a drug-free workplace.
Location:
Parsippany, New Jersey
Senior Manager, Regulatory Affairs professionals in Parsippany
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