Welcome to Simply Hired!

Like what you see here? Check out more Managers, All Other jobs like this one.

Show Me More

Principal Regulatory Affairs Labeling, Promotion and Advertising

Apply Now

Company: Upsher-Smith Laboratories

Location: Osseo, MN

Date Posted: August 18, 2014

Source: Upsher-Smith Laboratories

The Regulatory Affairs Labeling, Promotion & Advertising Manager ensures compliance to internal labeling, promotion and advertising policies and procedures as well as regulations and guidance set forth by regulatory authorities. Additionally, this position is accountable for the development and delivery of training to applicable internal functions regarding current labeling, promotion and advertising regulations, FDA guidance, processes, and supporting tools. The position will be involved with responding to internal and external audits regarding labeling, advertising and promotional labeling, as applicable.

Support the management and implementation of the processes associated with the creation of new product labeling, and revisions to existing labeling content documents throughout the lifecycle of assigned products. Ensure the representation of labeling content is accurate on artwork, and that draft labeling is compliant with labeling regulations and FDA guidance. Participate in the development of labeling strategy, including ensuring that labeling content is sufficiently supported by submission documents, and remains current ...

The Regulatory Affairs Labeling, Promotion & Advertising Manager ensures compliance to internal labeling, promotion and advertising policies and procedures as well as regulations and guidance set forth by regulatory authorities. Additionally, this position is accountable for the development and delivery of training to applicable internal functions regarding current labeling, promotion and advertising regulations, FDA guidance, processes, and supporting tools. The position will be involved with responding to internal and external audits regarding labeling, advertising and promotional labeling, as applicable.

Support the management and implementation of the processes associated with the creation of new product labeling, and revisions to existing labeling content documents throughout the lifecycle of assigned products. Ensure the representation of labeling content is accurate on artwork, and that draft labeling is compliant with labeling regulations and FDA guidance. Participate in the development of labeling strategy, including ensuring that labeling content is sufficiently supported by submission documents, and remains current with labeling regulations and guidance as they pertain to assigned products.

Be accountable for assigned promotional regulatory activities, including participation during relevant product development and launch activities. This position is accountable for the regulatory affairs review and approval of assigned drug product advertising and promotional labeling as well as sales training materials to help ensure that the information contained in these materials are not false or misleading. Contributes to providing clear and unambiguous communication of the laws, regulations and regulatory agency guidance relating to product promotion to internal sponsors of communication activities or functions (e.g., Marketing, Medical Affairs (scientific publications), Public Relations (external presentations and press releases), and Sales Training (materials and tools).


A minimum of a Bachelors degree, typically from the pharmaceutical/health/science/nursing disciplines. Masters (MS) or Professional degree (JD, PharmD, MD) preferred. RAC preferred.

10 + years experience in the pharmaceutical industry (MS/ PharmD 4-7 years), with 7+ years experience in regulatory affairs required. Must have a minimum of 5 + years of regulatory affairs Advertising/Promotion and Labeling experience in the food, pharmaceutical, or medical device industries.

Must have a thorough understanding of the labeling development and advertising/promotional material review and approval processes and related issues (medical/safety/regulatory/corporate). The person must have proven ability to lead and work effectively in cross-functional teams to develop consensus on disparate issues, and have a good understanding of operations relevant to product manufacturing and packaging processes.

We are an equal opportunity employer. It is our policy to provide equal employment opportunities to all qualified persons without regard to race, color, creed, sex, religion, national origin, age, marital status, disability, sexual orientation, protected veteran status, or status with regard to public assistance, local human rights commission activity, genetic information or any other protected category and to comply with applicable federal, state and local regulations regarding discrimination in employment.



Required Skills


Required Experience
Show more

Other jobs you might like

  • Sr. Manager Regulatory Affairs

    Smiths Medical

    - Saint Paul, MN

    Company Description: Smiths Medical is a leading global provider of medical devices for the hospital, emergency, home and specialist environments. Our products are used during...

    28 days ago from ZipRecruiter
  • Director Regulatory Affairs

    NEW

    Covidien

    - Minneapolis, MN

    Manage a team responsible for regulatory submissions that bring medical innovations to market? Does this work inspire you? The Associate Director, Regulatory Affairs is...

    2 days ago from Covidien
  • Regulatory Change Project Manager

    US Bank

    - Minneapolis, MN

    Partners with multiple business lines within the bank and other team members to ensure regulatory changes are communicated and implemented in a controlled and coordinated manner.

    8 days ago from US Bank
  • Regulatory Change Project Manager

    U.S. Bancorp

    - Minneapolis, MN

    At U.S. Bank, we're passionate about helping customers and the communities where we live and work. The fifth-largest bank in the United States, we’re one of the country's most...

    9 days ago from U.S. Bancorp
  • Assistant Manager, Regulatory Affairs

    Ameriprise Financial

    - Minneapolis, MN

    Assistant Manager, Regulatory Affairs Job ID 2750BR Recruiting Location Minneapolis, MN Full-Time / Part-Time Full-Time Exempt/Non-Exempt Exempt Job Family Legal Affairs Job...

    10 days ago from Ameriprise Financial
  • Regulatory Affairs Associate Job

    3M

    - Saint Paul, MN

    Job ID: 54404 3M is seeking a Regulatory Affairs Associate for the Infection Prevention Division (IPD) located in Maplewood, Minnesota. Be part of what’s next! Job Summary : The...

    10 days ago from 3M
  • Regulatory Labeling Manager

    Endo Pharmaceuticals

    - Minneapolis, MN

    Regulatory Labeling Manager Location: MN - Minneapolis Position ID: P0007001 Description POSITION SUMMARY: Establishes and manages AMS Global Labeling function. Oversees the...

    17 days ago from Endo Pharmaceuticals
  • Regulatory Labeling Manager

    American Medical Systems

    - Minneapolis, MN

    POSITION SUMMARY: Establishes and manages AMS Global Labeling function. Oversees the development of labels and the labeling process throughout the product lifecycle. Provides...

    17 days ago from American Medical Systems.
  • Regulatory Affairs Manager

    Perrigo

    - Minneapolis, MN

    An exciting leadership opportunity is currently available at Perrigo’s facilities just outside of Minneapolis, Minnesota. We are currently searching for an experienced manager to...

    30+ days ago from Perrigo
  • Sr Regulatory Affairs Spec AF

    Medtronic

    - Mounds View, MN

    Medtronic is an Equal Opportunity/Affirmative Action Employer Position Description The Senior Regulatory Affairs Specialist will primarily represent regulatory affairs on product...

    30+ days ago from Medtronic

Show Me More

Were you satisfied with these results? Yes | No
Thank you for your feedback!