Sr Manager - Regulatory Advertising, Promotion and Labeling

Who we are…

Nuvation Bio is a biopharmaceutical company tackling some of the greatest unmet needs in oncology by developing differentiated and novel therapeutic candidates. Our vision is to significantly change the practice of oncology by developing medicines that provide truly meaningful improvements in quality of life and survival for people with cancer.

What you’ll be doing

As the Sr. Manager of Regulatory Advertising Promotion and Labeling you will be responsible to support the management of Nuvation's MLR review infrastructure and OPDP submission processes serve as the regulatory reviewer for assigned MLR review materials and support CCDS and label development tracking and life cycle management for Nuvation products.

You will be responsible for…

Advertising and Promotion:

• This individual will serve as the regulatory reviewer on assigned materials reviewing for compliance with applicable prescription drug regulations and company policies

• Serve as an active participant in MRL review meetings building and lending expertise in the assessment of MLR materials

• Will work with manager and MLR team to support the development and implementation of material review standards and strategies including both process and electronic review system enhancements to aid in the streamlined review and approval of MLR materials

• Collaborate with cross functional team members to ensure MLR materials are developed in accordance with internal processes and standards

• Responsible for all aspects of regulatory 2253 submission of promotional materials to FDA

• Develop and maintain strong working knowledge of scientific exchange and prescription drug external landscape including regulations guidances and enforcement trends. This individual will monitor for changes and work with manager to assess potential impact to Nuvation business and report out on same to colleagues in MLR review

Labeling:

• Develop and maintain knowledge of prescription drug labeling requirements and industry standards

• Support the development and life-cycle management of core product labeling (target-product-profile to CCDS to labeling text)

• Collaborate with cross functional team members for the development review and approval of labeling text for Nuvation products

• Contribute to the development of Nuvation's labeling processes and systems to support label function

What Knowledge & Experience you'll bring to us...

• Bachelors degree in scientific related field

• 2 year experience in regulatory affairs preferably in ad/prom or labeling function plus 4 years of experience in the pharmaceutical/biotech industry or related field.

• Highly-collaborative solutions oriented professional

• Strong communication (both oral and written) and negotiation skills able to articulate and defend regulatory position

• Well organized able to work under tight timelines with a strong attention to detail and recordkeeping ability

• Knowledge of FDA regulations for prescription drug promotion preferred

Behavioral skills to be successful...

• Problem-Solver - As an action-oriented self-starter you’re eager to apply your expertise in diagnosing inefficiencies determining root causes and recommending solutions to complex challenges.

• Personable - You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.

• Credible - Thorough understanding of clinical methodologies and providing sound analytical support you quickly establish credibility as a reliable resource.

• Emotional intelligence curiosity and a knack to figure out a way to build something better

• Communication - Effectively listens conveys and receives ideas. Maintains a consistent flow of information. A strong presenter and effective communicator with the ability to influence stakeholders.

• Accountability - Acts with a clear sense of ownership - whether the task is in their role description. Holds yourself and others accountable to execute all tasks at hand through seen and unforeseen circumstances with high quality and integrity.

• Adaptability - Can manage in an environment of ambiguity. Embraces the change of a new system process technology or idea in the organization. You could reassess priorities alter goals and take risks.

What we have for you!

• Competitive Base Salary Bonus and Equity Plans

• Unlimited Vacation and 10 Sick Days Annually

• Excellent Medical Dental and Vision Coverage

• 401K with Company Matching

• and much more!

The base pay offered will take into account internal equity and also may vary depending on the candidate’s job-related knowledge skills experience and location among other factors. Our full-time regular positions also include an annual performance-based bonus and long-term incentive units (equity) provided as part of our compensation package in addition to a full range of medical financial and/or other benefits depending on the level and position offered.

Disclaimer

Nuvation Bio Inc. is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity genetic information national origin protected veteran status disability status or any other characteristic protected by the law.

This job description reflects the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties responsibilities and qualifications required of employees assigned to this job. Nothing restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Note to all external Recruiters & Staffing Agencies All of our open positions are managed by our Talent Acquisition department. Any resumes submitted through the website or directly by recruiters or staffing agencies in advance of an executed agreement with Nuvation Bio Inc. will be considered unsolicited and the company will not be responsible for any related fees. Resumes sent directly to employees or hiring managers will also not be accepted as referrals.