Regulatory Affairs Manager Job

REGULATORY AFFAIRS MANAGER needed for a CONTRACT opportunity with Yoh's client located in Parsippany, NJ.

WHAT YOU'LL BE DOING:

- Collaborate closely with multi-disciplinary teams, relevant business groups and other functions as appropriate, to develop, in a timely manner, robust regulatory strategies for assigned global projects and products.
- Liaise with central and local market regulatory teams to ensure dissemination and implementation of the regulatory strategy, as well as providing support to commercial and market internal customers.
- Provide expert regulatory advice and guidance to development and commercial teams as appropriate.
- Manage global regulatory compliance of assigned products.
- Provide core documentation to enable registration/notification of our products under whatever legal classifications are appropriate.
- Orchestrate (with appropriate colleagues) the strategy and preparation of responses/position papers for regulatory authorities.
- Provide assistance, in collaboration with Regulatory Director and local market RA functions, with notified body/competent authority/regulatory agency meetings.
- Keep up-to-date with EU legislation relevant to product responsibilities (eg medicines/medical devices/cosmetics) and provide interpretation of regulatory changes and any potential project/product impacts.
- Maintain an awareness of key aspects of regulations in major global markets outside EU.
- Analyze and interpret available information to take balanced decisions independently within agreed remits.
- Effectively communicate information to ensure project risks, developments and outcomes are rapidly and efficiently highlighted to key stakeholders.
- Lead or participate in specific process/departmental improvement projects.
- Take active responsibility for personal and professional development.
- Assure compliance with corporate policies and standards and external regulatory requirements, including Health and Safety at Work.

WHAT YOU NEED TO BRING TO THE TABLE:

- Degree in a pharmaceutical or life science.
- Working knowledge of European and/or International regulatory affairs.
- OTC Drug experience is a must
- Previous experience in regulatory affairs or a related technical discipline.
- Understanding and knowledge of the product development process and associated regulatory processes and procedures.
- Knowledge of common technical document format and content for regulatory dossiers, variations, renewals and clinical trial applications.
- Direct experience with medicinal product regulations.
- Direct experience with cosmetic product regulations.
- Experience with medical device regulations.
- Proven record of developing regulatory strategies for complex situations.
- Experience of working flexibly across a portfolio of products.
- Awareness of regulatory processes in different geographic regions, for example emerging markets, Japan.
- Knowledge of eCTD and related electronic submission processes.
- Demonstrated ability to review and approve labeling and advertising materials.

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: Krista Leach

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here to contact us if you are an individual with a disability and require accommodation in the application process.

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