Top Regulatory Affairs Executive jobs in Methuen, MA

The Regulatory Affairs III Associate professional integrates regulatory knowledge throughout the product lifecycle with aspects of effective management and strategy development. This level represents the move from the technical and tactical dimensions of RA and the product lifecycle into a more strategic role.

OVERALL RESPONSIBILITIES:

Strategic Planning

• Evaluate regulatory risks of corporate policies

• Recruit, manage, develop and mentor regulatory professionals

• Develop new regulatory policies, procedures and SOPs and train key personnel on them

• Assist in the development and advancement of policy and procedures for regulatory affairs and compliance to establish a compliant culture within the organization

• Utilize technical regulatory skills to propose strategies on complex issues

• Monitor emerging issues and identify solutions

• Monitor trade association positions for impact on company products

• Provide regulatory input to product lifecycle planning

• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams

• Evaluate the effect of regulatory requirements on product positions

• Assist in the development of global, regional and multicounty regulatory strategy and update strategy based upon regulatory changes

• Determine submission and approval requirements

• Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management

• Assist in regulatory due diligence

Premarketing

• Provide strategic input and technical guidance on regulatory requirements to development teams

• Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions

• Evaluate proposed preclinical, clinical and manufacturing changes for regulatory filing strategies

• Manage and execute preapproval compliance activities

• Assess the acceptability of quality, preclinical and clinical documentation for submission filing

• Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval

• Identify issues early in the submission preparation process that could impact product launch

• Monitor impact of changing regulations on submission strategies and update internal stakeholders

• Prepare regulatory submissions

• Monitor and submit applicable reports and responses to regulatory authorities

• Monitor applications under regulatory review

• Propose risk-based decisions on special access approval with appropriate regulatory agencies to pursue approvals based on patient needs and risk assessment

Postmarketing

• Maintain annual licenses, registrations, listings and patent information

• Ensure compliance with product postmarketing approval requirements

• Review and approve labeling to ensure compliance with regulations and company policy

• Review and approve advertising and promotional items to ensure regulatory compliance

• Assess external communications relative to regulations

• Review publicly disseminated information to minimize regulatory exposure, review product claims and preserve confidentiality of applicable product information

• Review and approve required reports, supplemental submissions and other postmarketing commitments to update and maintain product approvals and registrations

• Provide regulatory input for and appropriate follow-up to inspections and audits

• Develop, implement and manage appropriate SOPs and systems to track and manage product-associated events

• Submit/review change controls to determine the level of change and consequent submission requirements

• Actively contribute to the development and functioning of the crisis/issue management program

• Identify product-associated problems and develop proposals for solutions

• Provide regulatory input for product recalls and recall communications

• Manage system to ensure that product safety issues and product-associated events are reported to regulatory agencies

• Report adverse events to regulatory agencies and internal stakeholders

Interfacing

• Provide training for stakeholders on current and new regulatory requirements to ensure

• company-wide compliance

• Communicate regulatory agency/industry positions to internal stakeholders

• Strategize with and advise internal stakeholders on regulatory issues

• Communicate and negotiate with regulatory authorities and stakeholders

• Conduct technical meetings with regulatory advisory committees and government agencies

• Communicate the impact of new, existing and pending regulations, guidelines

• and standards, and review committee recommendations to regulatory staff and internal stakeholders

• Participate in medical/scientific review and other relevant committees

• Accompany inspection team(s) as required

• Notify, consult or brief legal counsel when appropriate

• Participate and take leadership role in professional associations, industry/trade groups (local/regional/ international) and appropriate standards organizations

Requirements:
Bachelor’s degree or foreign equivalent in regulatory affairs, biomedical, mechanical, chemical, electrical, or biochemical engineering, chemistry, microbiology or a related field, plus three months of experience in the job offered or with medical, drug and/or biologics regulations, including premarket submissions for domestic and international markets.

Travel: No more than 20% at client sites nationwide.

Hours: 40/week, 9:00 a.m. – 5:30 p.m.

Location: 110 Haverhill Road, Suite 524, Amesbury, MA. 01913

Apply by resumes marked to:

Hiring Manager

Regulatory/Quality Management Information Source, Inc.

110 Haverhill Rd., Suite 524

Amesbury, MA 01913

978-358-7307

employment@rqmis.com