25/07 PDA Consultants
Founder at PDA Consultants

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Manager/Assistant Manager - Regulatory Affairs - Pharmaceutical Industry (2-5 yrs)

Rajkot Job Code: 22549

This role will support South America and Europe :

- Develop new regulatory policies, processes and SOPs .

- Evaluate regulatory risks of division policies, processes, procedures.

- Provide regulatory input to product lifecycle planning.

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

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

- Compile, prepare, review and submit regulatory submission to authorities in assigned countries.

- Oversee processes involved with maintaining annual licenses, registrations, listings information.

- Provide regulatory support for internal and external audits

- Responsible to provide regulatory filing support for assigned geography

- Handling required submission activities (planning, obtaining required data, coordination, reviewing, and release) in accordance to regulatory requirements and project timelines

- Responding to health authority questions or local subsidiary requests for additional information to support the assigned geography

- Work closely with various stakeholders to ensure timely follow-ups and receipt of documents for compiling submission packages in electronic/hardcopy format.

- Collaborative interaction to ensure quality, right first-time output and timeliness.

- Monitor document availability status and escalate delays to avoid risk(s).

- Setting-up and coordinating meetings and managing submission activities.

Qualifications :

Mandatory :

- Bachelor's degree, preferably in Pharmacy, Biological Science, Chemistry related discipline required with relevant experience in the pharmaceutical industry.

- Alternatively, a Master's or other advanced degree, preferably in Pharmacy, Biological Science, with at least 2 year of relevant experience in pharmaceutical industry in relevant role.

Other expertise :

- Understanding of regulatory requirements of India ( must) & South American & European countries ( preferred)

- Excellent organisational skills and a proven ability to multi-task

- Demonstrated oral and written communication skills and the ability to communicate issues in English. Strong listening skills.

- Demonstrated understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).

- Demonstrated proficiency in advanced document management system.

- Superior attentiveness to detail.

- Capability to handle multiple priorities and balance work to achieve business goals.

- Ability to prioritise tasks to meet deadlines and collaborate with a team when help is needed.

- Ability to identify problems and work with team to formulate a potential course of action

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