Regulatory Affairs Director, R&D, Respirent Pharmaceuticals

Regulatory Affairs Director, R&D, Respirent Pharmaceuticals

Respirent Pharmaceuticals is an innovative company which is focusing on the research, development, production and sales of respiratory medicines. As an international pharmaceutical company in respiratory area, Respirent is dedicated to provide affordable respiratory medicines for patients worldwide.

Primary role of regulatory affairs (RA) director is to lead Respirent regulatory affairs team, provide RA strategies and ensure RA objectives achieved successfully for Respirent products as the portfolio and organization expand.

Core Accountabilities/Responsibilities

Lead the development and implementation of the regulatory strategy, and ensure global and/or regional regulatory team to achieve the regulatory objectives in line with qualities and timelines.

Lead the management, planning, coordination, and preparation of documents that are submitted to regulatory authorities (including FDA, EMA, etc), in support of ANDAs, DMFs, etc.

Serve as the primary interface with regulatory authorities on assigned projects, and prepare project/study team for regulatory authority meetings, as required.

Represent regulatory affairs on various cross-functional teams, and work with cross-functional teams to define contributions to submissions, and represent regulatory affairs in senior management discussions and present issues accordingly.

Monitor changes in the regulatory environment, both general and specific to the therapeutic area, interpret and communicate regulatory expectations to internal and external stakeholders in order to execute objectives in compliance with applicable regulations.

Lead the development and maintenance of Regulatory Affairs working practices and procedures.

Lead the skill-development, coaching, and performance feedback of other regulatory staffs working on the products/projects.

Requirements

Master degree or above in related disciplines.

5+ years’ work experience in regulatory affairs of pharmaceutical industry or related area.

Generic drug experience highly preferred, especially in US ANDA.

DPI or inhalation product experience highly preferred.

Strong understanding of overall drug development and global/regional regulatory science, with a focus on US ANDA processes.

Familiar with CMC (Chemistry), manufacturing and control section for ANDA filing.

Good computer skills.

Strong ability in English, including listening, speaking, reading and writing.

Excellent leadership skills.

Demonstrated ability for critical thinking, problem-solving and innovation.

Strong interpersonal skills to ensure effective communication, collaboration and negotiation.

Strong project management and organizational skills, prioritizes and plans work activities.

2. Analytical R&D Director, Respirent Pharmaceuticals

Job Description

Primary role of analytical R&D director is tolead Respirent analytical R&Dteam, provide analytical strategies and ensure analytical objectives achieved successfully for Respirent products as the portfolio and organization expand.

Core Accountabilities/Responsibilities

Lead Respirent analytical activities and provide analytical strategies to meet the expanding needs of the Respirent product pipeline.

Oversee method development, specifications, release assays and certification, stability studies, comparability assessments, process analyses and validations of Respirent portfolio, and provide technical expertise in the areas of UP/HPLC, GC, MS, UV/Vis, Karl Fisher and other analytical techniques as required.

Establish an effective department infrastructure and systems to enable efficient method development, specification setting, and method transfer by leveraging internal and external expertise and capabilities.

Be responsible for the group's scientific and technical standards, critical review of documentation and reports, and hold reviewer/approver responsibility for appropriate analytical science sections of regulatory submissions.

Audit and review procedures, processes, data and laboratory preparedness for inspections, and participate in external and internal audits as required.

Develop the analytical staff to function effectively in cross-functional teams and collaboration, and provide input into personnel decisions including performance appraisals, promotions, and hiring, mentoring, and other personnel related activities.

Interact effectively and transparently with functional heads within Respirent, and with other Respirent stakeholders, and serve as a key strategic member of the development leadership team, assessing capabilities and processes and providing guidance for best practices and directions for continuous improvement.

Requirements

PhD degree in Pharmaceutical Analytical chemistry or related disciplines.

5+ years’ work experience in analytical science of pharmaceutical industry or related areas.

Generic drug experience highly preferred, especially in US ANDA.

DPI or inhalation product experience preferred.

Strong understanding of analytical techniques and knowledge of pharmaceutical analytical development.

Good computer skills and strong analytical technique skills.

Strong ability in English, including listening, speaking, reading and writing.

Excellent leadership skills.

Demonstrated ability for critical thinking, problem-solving and innovation.

Strong interpersonal skills to ensure effective communication, collaboration and negotiation.

Strong project management and organizational skills, prioritizes and plans work activities.

Strong sense of value of investment and ability to develop cost-effective development plans.

Potential to take on increasing responsibilities as the portfolio and organization expands.

3.Formulation R&D Director, Respirent Pharmaceuticals

Job Description

Primary role of formulation R&D director is to lead Respirent formulationR&D team, provide formulation strategies and ensure formulation objectives achieved successfully for Respirent products as the portfolio and organization expand.

Core Accountabilities/Responsibilities

Lead Respirent formulation activities and provide formulation strategies to meet the expanding needs of the Respirent product pipeline.

Oversee formulation development of Respirent portfolio, and provide technical expertise in the areas of formulation techniques as required.

Establish an effective department infrastructure and systems to enable efficient formulation development by leveraging internal and external expertise and capabilities.

Audit and review procedures, processes, data and laboratory preparedness for inspections, and participate in external and internal audits as required.

Develop the formulation staff to function effectively in cross-functional teams and collaboration, and provide input into personnel decisions including performance appraisals, promotions, and hiring, mentoring, and other personnel related activities.

Requirements

PhD degree in Formulation or related disciplines.

5+ years’ work experience in formulation science of pharmaceutical industry or related areas.

Generic drug experience highly preferred, especially in US ANDA.

DPI or inhalation product experience highly preferred.

Strong understanding of formulation techniques (DPI or inhalation, etc) and knowledge of pharmaceutical formulation development.

Good computer skills and strong formulation technique skills.

Strong ability in English, including listening, speaking, reading and writing.

Excellent leadership skills.

Demonstrated ability for critical thinking, problem-solving and innovation.

Strong interpersonal skills to ensure effective communication, collaboration and negotiation.

Strong project management and organizational skills, prioritizes and plans work activities.

Strong sense of value of investment and ability to develop cost-effective development plans.

Potential to take on increasing responsibilities as the portfolio and organization expands.

4.Quality Control Manager, R&D, Respirent Pharmaceuticals

Job Description

Primary role of quality control (QC) manager is to lead Respirent QC team, provide QC strategies and ensure QC objectives achieved successfully for Respirent products as the portfolio and organization expand.

Core Accountabilities/Responsibilities

Prioritize and delegate work functions to support timely testing and release of forecasted incoming samples, and coordinate cross-functional, intra-departmental and inter-departmental work assignments.

Manage all QC laboratory data to include, ensure all test methods comply with cGMP regulations and company policies, investigate laboratory anomalies, evaluate laboratory trends and archive raw data and results for easy retrieval.

Oversee laboratory supply and equipment ordering and maintain ordering within budgetary guidelines, and assure that the equipments are calibrated and qualified to the degree suitable for their intended use and regulatory requirements.

Prepare and review SOPs and department policies, and work closely with QA to implement procedures in compliance with regulatory requirements.

Manage all Quality Control personnel, which may include incoming associates, and ensure training is maintained and enforces adherence to SOPs.

Represent QC department in client and regulatory audits and participate in responses for audit observations.

Requirements

Master degree or above in Chemistry or related disciplines, PhD degree highly preferred.

5+ years’ experience of QC functions in pharmaceutical industry or related areas.

cGMP experience highly preferred.

Generic drug experience highly preferred, especially in US ANDA.

DPI or inhalation product experience highly preferred.

Strong knowledge of cGMP, pharmacopeia methods and requirements, regulatory guidelines, etc.

Good computer skills and strong QC technique skills.

Strong ability in English, including listening, speaking, reading and writing.

Excellent leadership skills.

Excellent verbal, written, interpersonal, organizational and communication skills.

Ability to operate in a fast-paced, multi-disciplinary industrial environment.

Effective problem solving skills and results orientated.

Ability to effectively manage multiple projects to meet timeline, technical and quality requirements.

5.Quality Assurance Manager, R&D, Respirent Pharmaceuticals

Primary role of quality assurance manager is to lead Respirent quality assurance (QA) team, provide QA strategies and ensure QA objectives achieved successfully for Respirent products as the portfolio and organization expand.

Core Accountabilities/Responsibilities

Provide direction and guidance for development, improvement, implementation, and maintenance of the entire quality system for the company.

Lead internal and external audits to ensure compliance with current Good Manufacturing Practices (cGMP) in accordance with regulatory standards, and to ensure integrity of data to support regulatory filings.

Develop proactive approaches to implement quality standards, policies and procedures for cGMP regulatory compliance.

Facilitate cGMP training of functional areas and develop training sessions.

Participate in regulatory agency inspections of cGMP inspections and follow-up to resolve audit findings.

Provide guidance on interpretation and application of cGMP regulations and guidance documents

Provide input to the preparation of documents for internal reports, external partner reports and/or regulatory filings, as needed.

Requirements

Master degree or above in related disciplines.

5+ years’ work experience in quality assurance of pharmaceutical industry or related area.

Generic drug experience highly preferred, especially in US ANDA.

DPI or inhalation product experience highly preferred.

Experience in a quality environment with expertise in cGMP.

Experience with documentation systems, document review and auditing responsibilities.

Strong knowledge of cGMP regulations.

Good computer skills.

Strong ability in English, including listening, speaking, reading and writing.

Ability to operate in a fast-paced, multi-disciplinary industrial environment.

Strong verbal and written communication skills and detail orientation required

Proactive, independent, hard-working and committed to achieving difficult goals.

6. Business Development Director, R&D, Respirent Pharmaceuticals

Primary role of business development director is to lead Respirent business development team, provide BD strategies and ensure BD objectives achieved successfully for Respirent products as the portfolio and organization expand.

Core Accountabilities/Responsibilities

Evaluate and manage new and existing external strategic business relationships and initiatives, including partnerships, alliances and/or joint ventures, involving a wide range of affairs including technology providers, strategic suppliers, channel partners, strategic customers, etc.

Provide leadership in the planning, designing, due diligence, and implementing of strategic business objectives.

Lead the In- and Out-licensing activities and support patent-strategy and -portfolio.

Generate and secure a continuous flow of attractive partnership opportunities that lead to a number of high value agreements, and to ensure quality relationships with each partner throughout the entire lifecycle of these partnerships

Lead the preparation, negotiation and implementation of business partnership agreements and contracts

Monitor partnership value and performance over time (e.g., revenues and profits), identify stars and laggards, and initiate appropriate action

Connect employees to the goals and objectives of the company by communicating and translating company objectives for each functional area, department, and individual. Ensure that sound objectives are prepared throughout area of responsibility.

Perform other duties and responsibilities assigned by CSO.

Requirements

Master degree or above, with MBA preferred.

5+ years’ work experience in business development of pharmaceutical industry or related areas.

Generic drug experience highly preferred, especially in US ANDA.

DPI or inhalation product experience highly preferred.

Strong understanding of relevant markets, strategies, and products/services with multi-disciplinary background by education and/or experience.

Good computer skills and financial analysis skills.

Strong ability in English, including listening, speaking, reading and writing.

Excellent leadership skills and problem-solving skills.

Strategic thinking.

Conflict management and negotiation skills.

Strong communication & information sharing skills (oral and written).

Consensus and relationship building (in industry).

7. Medical Device RA Manager, R&D, Respirent Pharmaceuticals

Primary role of medical device regulatory affairs manager is to lead Respirent medical device regulatory affairs (RA) team, provide medical device RA strategies and ensure medical device RA objectives achieved successfully for Respirent products as the portfolio and organization expand.

Core Accountabilities/Responsibilities

Develop sound global medical device regulatory strategies for new and modified medical devices, and prepare robust medical device regulatory applications to achieve objectives.

Review protocols and reports to support medical device regulatory submissions, and assess proposed medical device regulations and communicates new medical device requirements to the organization.

Review device labeling and marketing materials for compliance with regulatory authorities (FDA, EMA, etc) and applicable regulations.

Review product and manufacturing changes for compliance with applicable regulations (Change Control).

Independently interact and build partnerships with regulatory authorities (FDA, EMA, etc).

Provide medical device regulatory leadership to teams: global strategic input (including all feasible alternatives and associated risks) and driving cross functional alignment with issues that could have regulatory ramifications.

Provide leadership and guidance (including training) to other members of the medical device RA staff.

Requirements

Master degree or above in related disciplines.

5+ years’ regulatory experience in medical device or related areas.

Generic drug experience highly preferred, especially in US ANDA.

DPI or inhalation product experience highly preferred.

Strong knowledge with 510(k) applications, PMA supplements and US Class III device regulations and/or knowledge with EU and other international medical device regulations and submissions.

Good computer skills.

Strong ability in English, including listening, speaking, reading and writing.

Excellent problem-solving skills.

Strong interpersonal skills, organizational skills and attention to detail.

Strong communications with ability to effectively communicate at multiple levels in the organization.

Ability to leverage and/or engage others to accomplish projects.

Multitasks, prioritizes and meets deadlines in timely manner.

8. E&L Team Manager, R&D, Respirent Pharmaceuticals

Primary role ofExtractables&Leachables (E&L) manager is to lead Respirent E&L study team, provide E&Lstudy strategies and ensure objectives achieved successfully for Respirent products as the portfolio and organization expand.

Core Accountabilities/Responsibilities

Lead Respirent E&L studies and provide analytical strategies to meet the expanding needs of the Respirent product pipeline.

Design, plan, monitor and conduct the Extractables&Leachables method development and validation for Respirent portfolio, and provide technical expertise in the areas of UP/HPLC, GC, MS, UV/Vis, Karl Fisher and other analytical techniques as required.